AORTIC VALVE DISEASESNCT06830499
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
An observational study of AORTIC VALVE DISEASES and Bicuspid Aortic Valve (BAV), run by Xijing Hospital at 4 sites in China.
Trial summary
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
- What is being tested?
- Transcatheter Aortic Valve Replacement (TAVR)
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 4 sitesChina
- Study dates
- 24 Apr 2025to 30 Jun 2031
- Phase
- Observational
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Young (50~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population
Who may be able to join
- Subjects must meet ALL of the following inclusion criteria to be eligible for participation:
- 50 years of age or older but ≤70 years old at time of consent.
- Severe AS, defined as follows:
- For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
- Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.
- 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) of the respective clinical site.
Who cannot join
- Subjects are NOT eligible for participation if they meet ANY of the following exclusion criteria:
- Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).
- Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.
- Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.
- Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease).
Show all 19Show fewer
- Aortic disease: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid aortic valve with an ascending aorta diameter ≥ 50mm.
- Pre-existing mechanical or bioprosthetic valve in any position.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.
- Emergency interventional/surgical procedures within 30 days of the valve implant procedure.
- Hypertrophic cardiomyopathy with or without obstruction.
- Ventricular dysfunction with LVEF < 30%.
- Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation.
- Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel.
- Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure.
- Renal replacement therapy at the time of screening.
- Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen.
- Estimated life expectancy < 24 months.
- Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
Xiangbin Pan, MD, PhD
Xiangbin Pan, MD, PhD
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Yingqiang Guo, MD, PhD
Yingqiang Guo, MD, PhD
- Recruiting
Shanghai Zhongshan Hospital, Fudan University
Shanghai
Lai Wei, MD, PhD
Lai Wei, MD, PhD
- Recruiting
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi, 710032
Jian Yang, MD, PhD, +8613892828016, yangjian@fmmu.edu.cn
Meng en Zhai, PhD, +8617782801836, zhaimengen@126.com
About this study
Official title: Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
Read the detailed description
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis (AS). Currently TAVR indication has expanded to intermediate and low-risk patients from inoperable or high-risk patients, through a rigorous series of clinical trials comparing TAVR with surgical aortic valve replacement (SAVR).
Despite 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommended SAVR for patients with symptomatic severe AS aged <65 years, the previous data from United States nationwide Vizient Clinical Data Base and Northern New England Cardiovascular Disease Group Consortium (NNECDSG) registry demonstrated dramatic growth in TAVR utilization in younger patients aged <65 years from 2015 to 2021/2022, which is possibly driven by increased TAVR utilization in low surgical risk patients.
However, TAVR has never been systematically tested in young (<65 years old), low-risk patients, with many unanswered questions, especially the safety and effectiveness of TAVR in patients with bicuspid aortic valves and the durability of transcatheter heart valves. Furthermore, we noticed that the patients between 65 years old and 70 years old accounted for 23.3% of all the TAVR patients and this patient subgroup were underrepresented in the previous study, which makes it necessary to also explore the interested endpoints in this subgroup.
The aim of this study is to establish the safety and efficacy of Sapien 3 TAVR in young (50~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population and to explore the durability performance of Sapien 3 in this cohort.
- Conditions
- AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
- Being tested
- Transcatheter Aortic Valve Replacement (TAVR)
- Keywords
- TAVR, real-world, aortic valve stenosis, Sapien 3
- Medical subject headings
- Aortic Valve Disease, Bicuspid Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Replacement (TAVR)Procedure or surgery
TAVR procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. Vascular access site will be through transfemoral on the basis of pre-procedural evaluation of access site vessel. The procedure will be performed under local or general anesthesia and per clinical practice standard.
| Study group | Role | What they receive |
|---|---|---|
| 300 retrospectively enrolled patients | Procedure: TAVR Receives: Procedure: Transcatheter Aortic Valve Replacement (TAVR) | |
| 150 prospectively enrolled patients | Procedure: TAVR Receives: Procedure: Transcatheter Aortic Valve Replacement (TAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The primary end point is the 5 year all-cause mortality
Measured: At 5 years
Secondary outcomes (21)
The composite of all-cause mortality, stroke and rehospitalization
The composite of all-cause mortality, stroke, rehospitalization (procedure, valve and heart failure related) at 30 days, 1, 3, 5 years
Measured: At 30 days, 1, 3, 5 years
The composite of device success
The composite of device success at 30 days comprising the following: freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication, intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation), according to the VARC-3 definition
Measured: At 30 days
The durability performance of Sapien 3
The durability performance of Sapien 3 at 1, 3, 5 years: bioprosthetic valve dysfunction (BVD, including SVD, non-SVD, endocarditis and thrombosis), moderate or severe hemodynamic valve deterioration (HVD), bioprosthetic valve failure (BVF) according to the VARC-3 definition, EOA/mean gradient (MG) change over follow up
Measured: At 1, 3, 5 years
Annular rupture
The incidence of annular rupture
Measured: At 1 day of discharge
Paravalvular leakage
The incidence of paravalvular leakage
Measured: At 1 day of discharge, 30 days, 1, 3, 5 years
Technical success
Technical success (at exit from procedure room):
- freedom from mortality
- successful access, delivery of the device, and retrieval of the delivery system
- correct positioning of a single prosthetic heart valve into the proper anatomical location
- freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Measured: At exit from procedure room
Procedural success
Procedural success at 30 days defined as meeting all of the following:
- Device success
- No device or procedure related SAE's as follows:
- Life-threatening bleed (BARC 3b or greater)
- Major vascular or cardiac structural complications requiring unplanned reintervention or surgery
- Stage 2 or 3 AKI (includes new dialysis)
- MI or need for PCI/CABG
- Severe heart failure or hypotension requiring IV inotrope >12 hours, ultrafiltration or mechanical circulatory support
- Prolonged intubation > 48 hours
- Need for a permanent pacemaker implant or continuous, new onset atrial fibrillation
Measured: At 30 days
Mortality (all cause & cardiovascular)
The incidence of mortality (all cause \& cardiovascular)
Measured: At 30 days, 1, 3, 5 years
Stroke (disabling and nondisabling)
The incidence of stroke (disabling and nondisabling)
Measured: At 30 days, 1, 3, 5 years
Rehospitalization (procedure, valve and heart failure related)
The incidence of rehospitalization (procedure, valve and heart failure related)
Measured: At 30 days, 1, 3, 5 years
Major vascular complication
The incidence of major vascular complication
Measured: At 30 days, 1, 3, 5 years
Major or life-threatening bleeding
The incidence of major or life-threatening bleeding
Measured: At 30 days, 1, 3, 5 years
Myocardial infarction
The incidence of myocardial infarction
Measured: At 30 days, 1, 3, 5 years
Acute kidney injury stage 2 or 3
The incidence of acute kidney injury stage 2 or 3
Measured: At 30 days, 1, 3, 5 years
Need for a permanent pacemaker
The incidence of permanent pacemaker implantation
Measured: At 30 days, 1, 3, 5 years
New onset atrial fibrillation
The incidence of new onset atrial fibrillation
Measured: At 30 days, 1, 3, 5 years
Valve endocarditis
The incidence of valve endocarditis
Measured: At 30 days, 1, 3, 5 years
Valve thrombosis
The incidence of valve thrombosis
Measured: At 30 days, 1, 3, 5 years
New York Heart Association class
The changes in New York Heart Association class
Measured: At 30 days, 1, 3, 5 years
Patient-prosthesis mismatch
The incidence of patient-prosthesis mismatch
Measured: At 30 days, 1, 3, 5 years
Health status as evaluated by Quality of Life questionnaires - KCCQ
The changes in Health status as evaluated by Quality of Life questionnaires - KCCQ
Measured: At baseline, 30 days, 1, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start24 Apr 2025
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AORTIC VALVE DISEASESStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Fu Wai Hospital, Beijing, China, West China Hospital
- Responsible party
- Sponsor
- Investigators
- Jian Yang, MD, PhD, Principal investigator, Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830499
- Sponsor's protocol ID
- China Young TAVR Study
- Status last verified
- May 2026
- First submitted
- 9 Jan 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
Publications
Ten Berg J, Sibbing D, Rocca B, Van Belle E, Chevalier B, Collet JP, Dudek D, Gilard M, Gorog DA, Grapsa J, Grove EL, Lancellotti P, Petronio AS, Rubboli A, Torracca L, Vilahur G, Witkowski A, Mehilli J. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J. 2021 Jun 14;42(23):2265-2269. doi: 10.1093/eurheartj/ehab196.
PubMed 33822924Gupta T, DeVries JT, Gilani F, Hassan A, Ross CS, Dauerman HL. Temporal Trends in Transcatheter Aortic Valve Replacement for Isolated Severe Aortic Stenosis. J Soc Cardiovasc Angiogr Interv. 2024 Apr 5;3(7):101861. doi: 10.1016/j.jscai.2024.101861. eCollection 2024 Jul. No abstract available.
PubMed 39132009Sharma T, Krishnan AM, Lahoud R, Polomsky M, Dauerman HL. National Trends in TAVR and SAVR for Patients With Severe Isolated Aortic Stenosis. J Am Coll Cardiol. 2022 Nov 22;80(21):2054-2056. doi: 10.1016/j.jacc.2022.08.787. Epub 2022 Sep 16. No abstract available.
PubMed 36122626Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
PubMed 30883053Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
PubMed 30883058Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
PubMed 28304219Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
PubMed 27040324Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
PubMed 21639811Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
- ClinicalTrials.gov ID
- NCT06830499
- Acronym / sponsor ID
- China Young TAVR Study
- Conditions
- AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
- Keywords
- TAVR, real-world, aortic valve stenosis, Sapien 3
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Fu Wai Hospital, Beijing, China, West China Hospital
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 17 Feb 2025 (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.
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
Detailed description
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis (AS). Currently TAVR indication has expanded to intermediate and low-risk patients from inoperable or high-risk patients, through a rigorous series of clinical trials comparing TAVR with surgical aortic valve replacement (SAVR).
Despite 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommended SAVR for patients with symptomatic severe AS aged <65 years, the previous data from United States nationwide Vizient Clinical Data Base and Northern New England Cardiovascular Disease Group Consortium (NNECDSG) registry demonstrated dramatic growth in TAVR utilization in younger patients aged <65 years from 2015 to 2021/2022, which is possibly driven by increased TAVR utilization in low surgical risk patients.
However, TAVR has never been systematically tested in young (<65 years old), low-risk patients, with many unanswered questions, especially the safety and effectiveness of TAVR in patients with bicuspid aortic valves and the durability of transcatheter heart valves. Furthermore, we noticed that the patients between 65 years old and 70 years old accounted for 23.3% of all the TAVR patients and this patient subgroup were underrepresented in the previous study, which makes it necessary to also explore the interested endpoints in this subgroup.
The aim of this study is to establish the safety and efficacy of Sapien 3 TAVR in young (50~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population and to explore the durability performance of Sapien 3 in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300 retrospectively enrolled patients | – | Procedure: Transcatheter Aortic Valve Replacement (TAVR)Procedure: TAVR |
| 150 prospectively enrolled patients | – | Procedure: Transcatheter Aortic Valve Replacement (TAVR)Procedure: TAVR |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Young (50~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population
Key inclusion criteria (8 listed)
- Subjects must meet ALL of the following inclusion criteria to be eligible for participation:
- 50 years of age or older but ≤70 years old at time of consent.
- Severe AS, defined as follows:
- Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Key exclusion criteria (19 listed)
- Subjects are NOT eligible for participation if they meet ANY of the following exclusion criteria:
- Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).
- Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.
- Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.
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 |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR)TAVR procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. Vascular access site will be through transfemoral on the basis of pre-procedural evaluation of access site vessel. The procedure will be performed under local or general anesthesia and per clinical practice standard. | Procedure or surgery | 150 prospectively enrolled patients, 300 retrospectively enrolled patients |
Primary outcome
All-cause mortality
Time frame: At 5 years
The primary end point is the 5 year all-cause mortality
21 secondary outcomes
The composite of all-cause mortality, stroke and rehospitalization
Time frame: At 30 days, 1, 3, 5 years
The composite of device success
Time frame: At 30 days
The durability performance of Sapien 3
Time frame: At 1, 3, 5 years
Annular rupture
Time frame: At 1 day of discharge
Paravalvular leakage
Time frame: At 1 day of discharge, 30 days, 1, 3, 5 years
Technical success
Time frame: At exit from procedure room
Procedural success
Time frame: At 30 days
Mortality (all cause & cardiovascular)
Time frame: At 30 days, 1, 3, 5 years
Stroke (disabling and nondisabling)
Time frame: At 30 days, 1, 3, 5 years
Rehospitalization (procedure, valve and heart failure related)
Time frame: At 30 days, 1, 3, 5 years
Major vascular complication
Time frame: At 30 days, 1, 3, 5 years
Major or life-threatening bleeding
Time frame: At 30 days, 1, 3, 5 years
Myocardial infarction
Time frame: At 30 days, 1, 3, 5 years
Acute kidney injury stage 2 or 3
Time frame: At 30 days, 1, 3, 5 years
Need for a permanent pacemaker
Time frame: At 30 days, 1, 3, 5 years
New onset atrial fibrillation
Time frame: At 30 days, 1, 3, 5 years
Valve endocarditis
Time frame: At 30 days, 1, 3, 5 years
Valve thrombosis
Time frame: At 30 days, 1, 3, 5 years
New York Heart Association class
Time frame: At 30 days, 1, 3, 5 years
Patient-prosthesis mismatch
Time frame: At 30 days, 1, 3, 5 years
Health status as evaluated by Quality of Life questionnaires - KCCQ
Time frame: At baseline, 30 days, 1, 3, 5 years
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 27 May 2026.
- Background: PubMed 33822924Ten Berg J, Sibbing D, Rocca B, Van Belle E, Chevalier B, Collet JP, Dudek D, Gilard M, Gorog DA, Grapsa J, Grove EL, Lancellotti P, Petronio AS, Rubboli A, Torracca L, Vilahur G, Witkowski A, Mehilli J. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J. 2021 Jun 14;42(23):2265-2269. doi: 10.1093/eurheartj/ehab196.
- Background: PubMed 39132009Gupta T, DeVries JT, Gilani F, Hassan A, Ross CS, Dauerman HL. Temporal Trends in Transcatheter Aortic Valve Replacement for Isolated Severe Aortic Stenosis. J Soc Cardiovasc Angiogr Interv. 2024 Apr 5;3(7):101861. doi: 10.1016/j.jscai.2024.101861. eCollection 2024 Jul. No abstract available.
- Background: PubMed 36122626Sharma T, Krishnan AM, Lahoud R, Polomsky M, Dauerman HL. National Trends in TAVR and SAVR for Patients With Severe Isolated Aortic Stenosis. J Am Coll Cardiol. 2022 Nov 22;80(21):2054-2056. doi: 10.1016/j.jacc.2022.08.787. Epub 2022 Sep 16. No abstract available.
- Background: PubMed 30883053Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
- Background: PubMed 30883058Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
- Background: PubMed 28304219Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
- Background: PubMed 27040324Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
- Background: PubMed 21639811Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Individual participant dataSharing planned: No. Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
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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 Yang, MD, PhD principal investigator
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AORTIC VALVE DISEASES and Bicuspid Aortic Valve (BAV), run by Xijing Hospital at 4 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 8 inclusion and 19 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Yang, MD, PhD (+8613892828016, yangjian@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: At 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830499, which also lists 9 linked publications.
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 27 May 2026.