Aortic StenosisNCT04722796
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
A study testing TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution) and TAVR with Venus A plus using annular sizing and THV implantation technique in people with Aortic Stenosis and Aortic Stenosis With Bicuspid Valve, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 18 sites in China.
Trial summary
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis, Aortic Stenosis With Bicuspid Valve
- What is being tested?
- TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution) and TAVR with Venus A plus using annular sizing and THV implantation technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 18 sitesChina
- Study dates
- 12 Apr 2021to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 65 years
- Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
- Severe, bicuspid aortic stenosis:
- Mean gradient ≥40 mmHg
- Maximal aortic valve velocity ≥4.0 m/sec
- Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)
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- NYHA classification ≥ II;
- Type 0, type 1 (Sievers classification) by MDCT
- Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;
- Transfemoral TAVR
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Who cannot join
- Any contra-indication for Self-expanding bioprosthetic aortic valve deployment
- Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL).
- Active sepsis, including active bacterial endocarditis with or without treatment;
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
- Estimated life expectancy < 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
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- Any Emergent surgery required before TAVR procedure.
- A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media
- Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- Subject refuses a blood transfusion.
- Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
- Currently participating in an investigational drug or another device study (excluding registries).
- Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Severe mitral stenosis amenable to surgical replacement or repair.
- Aortic valve type cannot be determined (Sievers classification).
- Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation>70°).
- Ascending aorta diameter > 50 mm.
- Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.
- Previous pacemaker implantation.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Not yet recruiting
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality
Yundai Chen
- Not yet recruiting
The First affiliated hospital of bengbu medical college
Bengbu, Anhui
Shili Wu, chinawsl@126.com
- Not yet recruiting
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan
Zhengfei Fang, fangzhenfei@csu.edu.cn
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Lianglong Cheng, lianglongchen@126.com
- Not yet recruiting
Guangdong People's Hospital
Guangzhou, Guangdong
Jianfang Luo, jianfangluo@sina.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, 310006
Jian'an Wang, MD, wja@zju.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaoping Peng, cdyfypxp@163.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yanqing Wu, wuyanqing01@sina.com
- Recruiting
Ning Bo First Hospital
Ningbo, Zhejiang, 315010
Xiaomin Cheng, chxmin@hotmail.com
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Lei Jiang, anjianer@126.com
- Not yet recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
Jian An, anjianer@126.com
- Not yet recruiting
tianjin Chest Hospital
Tianjing, Tianjing, 300222
Nan Jiang, tjxkcs2@163.com
- Recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaoke Shang, 14236338@qq.com
- Not yet recruiting
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian
Yan Wang, wy@medmail.com.cn
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Shenghu He, yzhshys@163.com
- Not yet recruiting
Zhengzhou Cardiovascular Hospital
Zhengzhou, Henan, 450016
Shenwei Zhang, zhangsw214@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Jianzeng Dong, jz_dong@126.com
- Not yet recruiting
Hennan Provincial Chest Hospital
Zhengzhou, Hennan
Yiqiang Yuan, zzqyuanyiqiang@126.com
About this study
Official title: HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
Read the detailed description
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.
Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are more common among TAVR candidates. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS, especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points provide the definition of the annulus plane, current CT-based annulus measurements might not be accurate under these circumstances. From previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, indicating that the supra-annular structure may serve a key role in anchoring the THV.
Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for SEV implantation in bicuspid AS. From our single center experience, the device success rate and pacemaker implantation rate were relatively low.
The aim of this study is to compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs).
- Being tested
- TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution), TAVR with Venus A plus using annular sizing and THV implantation technique
- Keywords
- Transcatheter aortic valve replacement, Aortic Stenosis with Bicuspid Valve, supra-annular sizing
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)Device
Also called Hangzhou solution
Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
TAVR with Venus A plus using annular sizing and THV implantation techniqueDevice
Also called Traditional sizing strategy (Annulus based sizing strategy)
Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)
| Study group | Role | What they receive |
|---|---|---|
| TAVR with Supra-annular sizing strategy | Experimental | Experimental: Supra-annular sizing strategy (Hangzhou Solution).
Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size.
Waist sign with less than mild contrast regurgitation: Venus A plus Valve down size and Target implant depth 0-2mm.
No waist sign and/or contrast regurgitation or unable to finish supra-annular sizing: annular sizing Venus A plus Valve with implant depth 4-6mm. Receives: Device: TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution) |
| TAVR with Annulus based sizing strategy | Other | Control: Traditional sizing strategy (Annulus based sizing strategy).
Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size.
Annular sizing Venus A plus Valve with implant depth 4-6mm. Receives: Device: TAVR with Venus A plus using annular sizing and THV implantation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month
Composite of all-cause mortality, disabling stroke, new permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation at 1 month (per Valve Academic Research Consortium-2 [VARC-2] criteria)
Measured: 1 month
Secondary outcomes (82)
Deaths (all-cause mortality) at 1 month
Number of deaths from any cause mortality at 1 month
Measured: 1 month
Deaths (all-cause mortality) at 1 year
Measured: 1 year
Deaths (all-cause mortality) at 2 years
Measured: 2 years
Deaths (all-cause mortality) at 3 years
Measured: 3 years
Deaths (all-cause mortality) at 4 years
Measured: 4 years
Deaths (all-cause mortality) at 5 years
Measured: 5 years
All Stroke (disabling and non-disabling) at 1 month
duration of a focal or global neurological deficit >24 h; OR <24 h if available neuroimaging documents a new haemorrhage or infarct; OR the neurological deficit results in death
Measured: 1 month
All Stroke (disabling and non-disabling) at 1 year
Measured: 1 year
All Stroke (disabling and non-disabling) at 2 years
Measured: 2 years
All Stroke (disabling and non-disabling) at 3 years
Measured: 3 years
All Stroke (disabling and non-disabling) at 4 years
Measured: 4 years
All Stroke (disabling and non-disabling) at 5 years
Measured: 5 years
Rate of New permanent pacemaker implantation at 1 month
Rate of New permanent pacemaker implantation (e.g. defibrillator, single vs. dual chamber, biventricular)
Measured: 1 month
Rate of New permanent pacemaker implantation at 1 year
Measured: 1 year
Rate of New permanent pacemaker implantation at 2 years
Measured: 2 years
Rate of New permanent pacemaker implantation at 3 years
Measured: 3 years
Rate of New permanent pacemaker implantation at 4 years
Measured: 4 years
Rate of New permanent pacemaker implantation at 5 years
Measured: 5 years
Rate of Moderate or severe prosthetic valve regurgitation at 1 month
Moderate or severe prosthetic valve regurgitation by transthoracic echocardiography, VARC-2 definition
Measured: 1 month
Rate of Moderate or severe prosthetic valve regurgitation at 1 year
Measured: 1 year
Rate of Moderate or severe prosthetic valve regurgitation at 2 years
Measured: 2 years
Rate of Moderate or severe prosthetic valve regurgitation at 3 years
Measured: 3 years
Rate of Moderate or severe prosthetic valve regurgitation at 4 years
Measured: 4 years
Rate of Moderate or severe prosthetic valve regurgitation at 5 years
Measured: 5 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 month
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications by VARC-2 definition
Measured: 1 month
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 year
Measured: 1 year
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 2 years
Measured: 2 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 3 years
Measured: 3 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 4 years
Measured: 4 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 5 years
Measured: 5 years
Rate of alternating valve of prosthetic valve size during TAVR
Alternating valve of prosthetic valve size during TAVR (up size or down size)
Measured: peri-procedural
Rate of valve malposition
Valve malposition (migration, embolization, and ectopic deployment)
Measured: peri-procedural
Rate of TAV-in-TAV deployment
TAV-in-TAV deployment (An additional valve prosthesis is implanted within a previously implanted prosthesis because of suboptimal device position and/or function, during the index procedure)
Measured: peri-procedural
Rate of device recapture or retrieval
Device recapture or retrieval peri-procedural
Measured: peri-procedural
Rate of conversion to open surgery
Conversion to open surgery (Conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications)
Measured: peri-procedural
Rate of unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure
Unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure
Measured: peri-procedural
Rate of coronary obstruction
Coronary obstruction (Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during the TAVR procedure)
Measured: peri-procedural
Major vascular complications (VARC 2)
Major vascular complications by VARC 2 definition
Measured: peri-procedural
Rate of annulus rupture
Procedural-related injuries occur in the region of the aortic root and the left ventricular outflow tract during transcatheter aortic valve replacement.
Measured: peri-procedural
Rate of structural valve deterioration at 1 month
Structural valve deterioration (2017 EAPCI/ESC/EACTS definition)
Measured: 1 month
Rate of structural valve deterioration at 1 year
Measured: 1 year
Rate of structural valve deterioration at 2 years
Measured: 2 years
Rate of structural valve deterioration at 3 years
Measured: 3 years
Rate of structural valve deterioration at 4 years
Measured: 4 years
Rate of structural valve deterioration at 5 years
Measured: 5 years
New onset complete LBBB before discharge
New onset complete LBBB, by 2009 AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III definition
Measured: before discharge
New onset complete LBBB at 1 month
Measured: 1 month
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at Baseline
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: Baseline
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 month
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: 1 month
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 year
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: 1 year
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 2 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: 2 years
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 3 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: 3 years
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 4 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: 4 years
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 5 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: 5 years
New York Heart Association (NYHA) Functional Class at baseline
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Measured: Baseline
New York Heart Association (NYHA) Functional Class at 1 month
Measured: 1 month
New York Heart Association (NYHA) Functional Class at 1 year
Measured: 1 year
New York Heart Association (NYHA) Functional Class at 2 years
Measured: 2 years
New York Heart Association (NYHA) Functional Class at 3 years
Measured: 3 years
New York Heart Association (NYHA) Functional Class at 4 years
Measured: 4 years
New York Heart Association (NYHA) Functional Class at 5 years
Measured: 5 years
Six Minute Walk Test (6MWT Distance or 6MWD) at baseline
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Measured: Baseline
Six Minute Walk Test (6MWT Distance or 6MWD) at 1 month
Measured: 1 month
Six Minute Walk Test (6MWT Distance or 6MWD) at 1 year
Measured: 1 year
Six Minute Walk Test (6MWT Distance or 6MWD) at 2 years
Measured: 2 years
Six Minute Walk Test (6MWT Distance or 6MWD) at 3 years
Measured: 3 years
Six Minute Walk Test (6MWT Distance or 6MWD) at 4 years
Measured: 4 years
Six Minute Walk Test (6MWT Distance or 6MWD) at 5 years
Measured: 5 years
Mini-Mental State Examination score at baseline
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: baseline
Mini-Mental State Examination score at 1 month
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: 1 month
Mini-Mental State Examination score at 1 year
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: 1 year
Mini-Mental State Examination score at 2 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: 2 years
Mini-Mental State Examination score at 3 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: 3 years
Mini-Mental State Examination score at 4 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: 4 years
Mini-Mental State Examination score at 5 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Measured: 5 years
Modified Rankin Scale Score at baseline
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:
0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: baseline
Modified Rankin Scale Score at 1 month
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: 1 month
Modified Rankin Scale Score at 1 year
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: 1 year
Modified Rankin Scale Score at 2 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: 2 years
Modified Rankin Scale Score at 3 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: 3 years
Modified Rankin Scale Score at 4 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: 4 years
Modified Rankin Scale Score at 5 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start12 Apr 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Venus MedTech (HangZhou) Inc., The First Affiliated Hospital of Bengbu Medical University, Chinese PLA General Hospital, Fujian Medical University Union Hospital, Xiamen University Affiliated Cardiovascular Hospital, The Second People's Hospital of GuangDong Province, Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Zhengzhou University, Henan Provincial Chest Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Central South University, Northern Jiangsu People's Hospital, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Affiliated Hospital of Qingdao University, Shanxi Cardiovascular Hospital, Tianjin Chest Hospital, Ning Bo First Hospital
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, PhD, MD, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722796
- Sponsor's protocol ID
- 2021-0007
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy
- ClinicalTrials.gov ID
- NCT04722796
- Acronym / sponsor ID
- 2021-0007
- Keywords
- Transcatheter aortic valve replacement, Aortic Stenosis with Bicuspid Valve, supra-annular sizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Venus MedTech (HangZhou) Inc., The First Affiliated Hospital of Bengbu Medical University, Chinese PLA General Hospital, Fujian Medical University Union Hospital, Xiamen University Affiliated Cardiovascular Hospital, The Second People's Hospital of GuangDong Province, Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Zhengzhou University, Henan Provincial Chest Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Central South University, Northern Jiangsu People's Hospital, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Affiliated Hospital of Qingdao University, Shanxi Cardiovascular Hospital, Tianjin Chest Hospital, Ning Bo First Hospital
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
Detailed description
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.
Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are more common among TAVR candidates. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS, especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points provide the definition of the annulus plane, current CT-based annulus measurements might not be accurate under these circumstances. From previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, indicating that the supra-annular structure may serve a key role in anchoring the THV.
Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for SEV implantation in bicuspid AS. From our single center experience, the device success rate and pacemaker implantation rate were relatively low.
The aim of this study is to compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR with Supra-annular sizing strategy | Experimental | Device: TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)Experimental: Supra-annular sizing strategy (Hangzhou Solution). Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size. Waist sign with less than mild contrast regurgitation: Venus A plus Valve down size and Target implant depth 0-2mm. No waist sign and/or contrast regurgitation or unable to finish supra-annular sizing: annular sizing Venus A plus Valve with implant depth 4-6mm. |
| TAVR with Annulus based sizing strategy | Other | Device: TAVR with Venus A plus using annular sizing and THV implantation techniqueControl: Traditional sizing strategy (Annulus based sizing strategy). Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size. Annular sizing Venus A plus Valve with implant depth 4-6mm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 65 years
- Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
- Severe, bicuspid aortic stenosis:
- Mean gradient ≥40 mmHg
- Maximal aortic valve velocity ≥4.0 m/sec
Key exclusion criteria (22 listed)
- Any contra-indication for Self-expanding bioprosthetic aortic valve deployment
- Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL).
- Active sepsis, including active bacterial endocarditis with or without treatment;
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)Also: Hangzhou solutionTranscatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution) | Device | TAVR with Supra-annular sizing strategy |
| TAVR with Venus A plus using annular sizing and THV implantation techniqueAlso: Traditional sizing strategy (Annulus based sizing strategy)Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy) | Device | TAVR with Annulus based sizing strategy |
Primary outcome
Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month
Time frame: 1 month
Composite of all-cause mortality, disabling stroke, new permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation at 1 month (per Valve Academic Research Consortium-2 [VARC-2] criteria)
82 secondary outcomes
Deaths (all-cause mortality) at 1 month
Time frame: 1 month
Deaths (all-cause mortality) at 1 year
Time frame: 1 year
Deaths (all-cause mortality) at 2 years
Time frame: 2 years
Deaths (all-cause mortality) at 3 years
Time frame: 3 years
Deaths (all-cause mortality) at 4 years
Time frame: 4 years
Deaths (all-cause mortality) at 5 years
Time frame: 5 years
All Stroke (disabling and non-disabling) at 1 month
Time frame: 1 month
All Stroke (disabling and non-disabling) at 1 year
Time frame: 1 year
All Stroke (disabling and non-disabling) at 2 years
Time frame: 2 years
All Stroke (disabling and non-disabling) at 3 years
Time frame: 3 years
All Stroke (disabling and non-disabling) at 4 years
Time frame: 4 years
All Stroke (disabling and non-disabling) at 5 years
Time frame: 5 years
Rate of New permanent pacemaker implantation at 1 month
Time frame: 1 month
Rate of New permanent pacemaker implantation at 1 year
Time frame: 1 year
Rate of New permanent pacemaker implantation at 2 years
Time frame: 2 years
Rate of New permanent pacemaker implantation at 3 years
Time frame: 3 years
Rate of New permanent pacemaker implantation at 4 years
Time frame: 4 years
Rate of New permanent pacemaker implantation at 5 years
Time frame: 5 years
Rate of Moderate or severe prosthetic valve regurgitation at 1 month
Time frame: 1 month
Rate of Moderate or severe prosthetic valve regurgitation at 1 year
Time frame: 1 year
Rate of Moderate or severe prosthetic valve regurgitation at 2 years
Time frame: 2 years
Rate of Moderate or severe prosthetic valve regurgitation at 3 years
Time frame: 3 years
Rate of Moderate or severe prosthetic valve regurgitation at 4 years
Time frame: 4 years
Rate of Moderate or severe prosthetic valve regurgitation at 5 years
Time frame: 5 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 month
Time frame: 1 month
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 year
Time frame: 1 year
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 2 years
Time frame: 2 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 3 years
Time frame: 3 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 4 years
Time frame: 4 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 5 years
Time frame: 5 years
Rate of alternating valve of prosthetic valve size during TAVR
Time frame: peri-procedural
Rate of valve malposition
Time frame: peri-procedural
Rate of TAV-in-TAV deployment
Time frame: peri-procedural
Rate of device recapture or retrieval
Time frame: peri-procedural
Rate of conversion to open surgery
Time frame: peri-procedural
Rate of unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure
Time frame: peri-procedural
Rate of coronary obstruction
Time frame: peri-procedural
Major vascular complications (VARC 2)
Time frame: peri-procedural
Rate of annulus rupture
Time frame: peri-procedural
Rate of structural valve deterioration at 1 month
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian'an Wang, PhD, MD study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution) and TAVR with Venus A plus using annular sizing and THV implantation technique in people with Aortic Stenosis and Aortic Stenosis With Bicuspid Valve, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian'an Wang, PhD, MD (+86057187783777, wja@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.