Severe Aortic Valve StenosisE-TAVR-2025NCT07108478
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
An observational study of Severe Aortic Valve Stenosis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis
- What is being tested?
- Transcatheter aortic valve and recyclable delivery system
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Dec 2028
- How long will I take part?
- 12 Months
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 1. Severe aortic stenosis 2, high risk of surgery, or surgical taboo, is not suitable for conventional surgery valve replacement; 3, anatomically suitable for TAVI/TAVR
Who may be able to join
- Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity ≥4.0m/s, or mean transvalvular pressure difference ≥40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area < <0.8cm2 (or effective aortic valve orifice area index < 0.5 cm2/m2);
- Meet one of the following emergent TAVR indications:
- 1) Shock; 2) Combined with persistent ventricular tachycardia or ventricular fibrillation; 3) Difficulty in improving unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance with drugs; 4) Cardiopulmonary resuscitation is required for cardiac arrest; 3. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept the relevant examinations and clinical follow-up.
Who cannot join
- Aortic root anatomy and lesions are not suitable for prosthetic valve implantation;
- Anatomic morphology or vascular diseases affecting the instrument approach;
- Left ventricular outflow tract obstruction;
- Primary dilated cardiomyopathy;
- Thrombus in the left ventricle;
- Patients who are unable to receive anticoagulation or antiplatelet therapy;
Show all 11Show fewer
- Allergy to or resistance to Nitinol;
- Active stage of infective endocarditis or other infection that the researcher believes affects the operation;
- Severe disability senile dementia;
- Patients with a life expectancy of less than half a year;
- The investigator determined that the patient or family had poor compliance or declined to complete the study as required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Chuanbao Li, +86 18560083097, bao2460@126.com
About this study
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. It is a prospective, multi-center clinical study, and 35 cases are planned to be enrolled and followed up for 12 months (before discharge, 30 days, 6 months and 12 months). The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function.
Read the detailed description
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. The prognosis of patients with severe aortic stenosis (AS) is extremely poor in emergency, and the mortality of traditional balloon angioplasty (PBAV) is high. As a new treatment method, emergency TAVR needs multi-center data to verify its safety and effectiveness. Based on the preliminary results of a single center, this study was extended to multiple centers in China, aiming at providing high-level evidence, helping to optimize the implementation strategy of emergency TAVR, and promoting its wide application in patients with severe aortic stenosis, thus improving the clinical prognosis and quality of life of patients. This study is a prospective, multi-center clinical study, and 35 patients are planned to be enrolled. All participants are followed up before discharge, 30 days, 6 months and 12 months after valve implantation, and the research unit independently manages data, including data collection, collation and statistical analysis. The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function. The selection criteria are: patients with severe aortic stenosis diagnosed by medical treatment; Meet one of the emergency TAVR indications (shock, persistent ventricular tachycardia or ventricular fibrillation, unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance devices, etc.); Voluntary participation and signing of informed consent. The main exclusion criteria are: aortic root anatomy and lesions are not suitable for artificial valve implantation; Anatomical morphology or vascular diseases that affect the instrument approach; Left ventricular outflow tract obstruction; Primary dilated cardiomyopathy; Thrombosis in left ventricle; Patients who cannot receive anticoagulant or antiplatelet therapy, etc. The statistical methods used are descriptive analysis, Kaplan-Meier survival analysis and Cox proportional hazard model (SAS 9.4). Following the Helsinki Declaration, China's Quality Management Standard for Clinical Trials of Medical Devices and ISO 14155:2011, all patients signed informed consent forms with the approval of the Ethics Committee.
- Conditions
- Severe Aortic Valve Stenosis
- Being tested
- Transcatheter aortic valve and recyclable delivery system
- Keywords
- Severe Aortic Valve Stenosis, TAVR, emergency
- Medical subject headings
- Aortic Valve Stenosis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve and recyclable delivery systemDevice
In this study, the transcatheter aortic valve and its recycling delivery system were VitaFlow Liberty®, a TAVR product independently developed by Shanghai Minimally Invasive Cardiovascular Treatment Co., Ltd. (approved and marketed by NMPA). This product is equipment/consumables routinely purchased by hospitals. For routine clinical use, it is designed for transcatheter aortic valve implantation. The valve is delivered to the intended implantation site via the peripheral artery by retrograde flow through the delivery system, realizing the delivery, positioning and release of the valve. Under the supervision of medical imaging equipment, the valve is delivered to the lesion site of the aortic valve, and marked by the diseased aortic annulus, to release the valve and relieve the stenosis at the lesion site, thereby ensuring smooth aortic flow, improving cardiac function and achieving therapeutic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described Receives: Device: Transcatheter aortic valve and recyclable delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative all-cause mortality at 12 months postoperatively
All-cause death includes cardiac death and non-cardiac death
Measured: 12 months
Secondary outcomes (10)
Incidence of major adverse cardiovascular events
Incidence of major adverse cardiovascular events (MACCE including mortality, disabling stroke, myocardial infarction, reoperation) calculated as number of occurrences/total number of occurrences
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Incidence of acute kidney injury
Incidence of acute kidney injury (AKIN Grade 2 or 3, or renal replacement therapy (RRT: hemodialysis, intraperitoneal dialysis, hemofiltration)) calculated as: Occurred/Total
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Incidence of permanent pacemaker implantation
Incidence of permanent pacemaker implantation, calculated as: Cases Occurred/Total Cases
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Incidence of severe vascular complications
Incidence of severe vascular complications, calculated as: number of cases/total number of cases
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
The incidence of other TAVR-related complications
The incidence of other TAVR-related complications, including conversion to surgical thoracotomy, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valvular ectopic (shift, embolism, false release), valvular implant, reoperation due to valve dysfunction (TAVR, SAVR, BAV), was calculated as: Cases Occurred/Total Cases
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Valve function (assessed by echocardiography)
Valve function (assessed by echocardiography): valve function (e.g., aortic valve orifice area, mean pressure differential across the aortic valve), valve regurgitation, perivalvular leakage, moderate or severe valve stenosis
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Change in cardiac function (NYHA)
NYHA classification: Divided into four levels, Grade I: No discomfort in daily activities, and no restriction in physical activities. Grade II: Mild activity restriction, no symptoms at rest, but daily activities (such as climbing stairs) can cause fatigue and palpitation. Grade III: obvious activity limitation, no symptoms at rest, but slight activity (such as walking) will cause symptoms. Grade Ⅳ: There are symptoms at rest, and any activity aggravates discomfort.
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Change in cardiac function (NT-proBNP)
NT-proBNP: Secreted by ventricular myocytes when the pressure load of the heart increases (such as heart failure and myocardial stretching), it is the precursor of BNP, obtained by laboratory examination
Measured: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Success rate of devices, calculation method: number of successful devices/total number of cases
calculation method: number of successful devices/total number of cases
Measured: Perioperative/Periprocedural
Implantation of mechanical circulation assistance device (MCS)
Implantation of mechanical circulation assistance device (MCS), calculated as: Cases of mechanical circulation assistance device implantation/Total cases
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start30 Jul 2025 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanbao Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108478
- Sponsor's protocol ID
- KYLL-202503-007-1
- Acronym
- E-TAVR-2025
- Status last verified
- Aug 2025
- First submitted
- 1 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kodali SK, Thourani VH, Kirtane AJ. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2016 Apr 21;374(16):1591. doi: 10.1056/NEJMc1600179. No abstract available.
PubMed 27096593Pache G, Schoechlin S, Blanke P, Dorfs S, Jander N, Arepalli CD, Gick M, Buettner HJ, Leipsic J, Langer M, Neumann FJ, Ruile P. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/eurheartj/ehv526. Epub 2015 Oct 7.
PubMed 26446193Frerker C, Schewel J, Schluter M, Schewel D, Ramadan H, Schmidt T, Thielsen T, Kreidel F, Schlingloff F, Bader R, Wohlmuth P, Schafer U, Kuck KH. Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis. EuroIntervention. 2016 Apr 20;11(13):1530-6. doi: 10.4244/EIJY15M03_03.
PubMed 25751886Huang H, Kovach CP, Bell S, Reisman M, Aldea G, McCabe JM, Dvir D, Don C. Outcomes of Emergency Transcatheter Aortic Valve Replacement. J Interv Cardiol. 2019 Nov 3;2019:7598581. doi: 10.1155/2019/7598581. eCollection 2019.
PubMed 31777471Bongiovanni D, Kuhl C, Bleiziffer S, Stecher L, Poch F, Greif M, Mehilli J, Massberg S, Frey N, Lange R, Laugwitz KL, Schymik G, Frank D, Kupatt C. Emergency treatment of decompensated aortic stenosis. Heart. 2018 Jan;104(1):23-29. doi: 10.1136/heartjnl-2016-311037. Epub 2017 May 31.
PubMed 28566471Block PC, Palacios IF. Clinical and hemodynamic follow-up after percutaneous aortic valvuloplasty in the elderly. Am J Cardiol. 1988 Oct 1;62(10 Pt 1):760-3. doi: 10.1016/0002-9149(88)91218-0.
PubMed 3421177Buchwald AB, Meyer T, Scholz K, Schorn B, Unterberg C. Efficacy of balloon valvuloplasty in patients with critical aortic stenosis and cardiogenic shock--the role of shock duration. Clin Cardiol. 2001 Mar;24(3):214-8. doi: 10.1002/clc.4960240308.
PubMed 11288967Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006 Oct 10;114(15):1616-24. doi: 10.1161/CIRCULATIONAHA.106.639450. Epub 2006 Oct 2.
PubMed 17015786Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
PubMed 12473543Leon 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 20961243Carabello BA, Paulus WJ. Aortic stenosis. Lancet. 2009 Mar 14;373(9667):956-66. doi: 10.1016/S0140-6736(09)60211-7. Epub 2009 Feb 21.
PubMed 19232707Supino PG, Borer JS, Preibisz J, Bornstein A. The epidemiology of valvular heart disease: a growing public health problem. Heart Fail Clin. 2006 Oct;2(4):379-93. doi: 10.1016/j.hfc.2006.09.010. No abstract available.
PubMed 17448426
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07108478
- Acronym / sponsor ID
- E-TAVR-2025 / KYLL-202503-007-1
- Conditions
- Severe Aortic Valve Stenosis
- Keywords
- Severe Aortic Valve Stenosis, TAVR, emergency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 7 Aug 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.
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. It is a prospective, multi-center clinical study, and 35 cases are planned to be enrolled and followed up for 12 months (before discharge, 30 days, 6 months and 12 months). The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function.
Detailed description
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. The prognosis of patients with severe aortic stenosis (AS) is extremely poor in emergency, and the mortality of traditional balloon angioplasty (PBAV) is high. As a new treatment method, emergency TAVR needs multi-center data to verify its safety and effectiveness. Based on the preliminary results of a single center, this study was extended to multiple centers in China, aiming at providing high-level evidence, helping to optimize the implementation strategy of emergency TAVR, and promoting its wide application in patients with severe aortic stenosis, thus improving the clinical prognosis and quality of life of patients. This study is a prospective, multi-center clinical study, and 35 patients are planned to be enrolled. All participants are followed up before discharge, 30 days, 6 months and 12 months after valve implantation, and the research unit independently manages data, including data collection, collation and statistical analysis. The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function. The selection criteria are: patients with severe aortic stenosis diagnosed by medical treatment; Meet one of the emergency TAVR indications (shock, persistent ventricular tachycardia or ventricular fibrillation, unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance devices, etc.); Voluntary participation and signing of informed consent. The main exclusion criteria are: aortic root anatomy and lesions are not suitable for artificial valve implantation; Anatomical morphology or vascular diseases that affect the instrument approach; Left ventricular outflow tract obstruction; Primary dilated cardiomyopathy; Thrombosis in left ventricle; Patients who cannot receive anticoagulant or antiplatelet therapy, etc. The statistical methods used are descriptive analysis, Kaplan-Meier survival analysis and Cox proportional hazard model (SAS 9.4). Following the Helsinki Declaration, China's Quality Management Standard for Clinical Trials of Medical Devices and ISO 14155:2011, all patients signed informed consent forms with the approval of the Ethics Committee.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case | – | Device: Transcatheter aortic valve and recyclable delivery system |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 1. Severe aortic stenosis 2, high risk of surgery, or surgical taboo, is not suitable for conventional surgery valve replacement; 3, anatomically suitable for TAVI/TAVR
Key inclusion criteria (3 listed)
- Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity ≥4.0m/s, or mean transvalvular pressure difference ≥40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area < <0.8cm2 (or effective aortic valve orifice area index < 0.5 cm2/m2);
- Meet one of the following emergent TAVR indications:
- 1) Shock; 2) Combined with persistent ventricular tachycardia or ventricular fibrillation; 3) Difficulty in improving unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance with drugs; 4) Cardiopulmonary resuscitation is required for cardiac arrest; 3. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept the relevant examinations and clinical follow-up.
Key exclusion criteria (11 listed)
- Aortic root anatomy and lesions are not suitable for prosthetic valve implantation;
- Anatomic morphology or vascular diseases affecting the instrument approach;
- Left ventricular outflow tract obstruction;
- Primary dilated cardiomyopathy;
- Thrombus in the left ventricle;
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 and recyclable delivery systemIn this study, the transcatheter aortic valve and its recycling delivery system were VitaFlow Liberty®, a TAVR product independently developed by Shanghai Minimally Invasive Cardiovascular Treatment Co., Ltd. (approved and marketed by NMPA). This product is equipment/consumables routinely purchased by hospitals. For routine clinical use, it is designed for transcatheter aortic valve implantation. The valve is delivered to the intended implantation site via the peripheral artery by retrograde flow through the delivery system, realizing the delivery, positioning and release of the valve. Under the supervision of medical imaging equipment, the valve is delivered to the lesion site of the aortic valve, and marked by the diseased aortic annulus, to release the valve and relieve the stenosis at the lesion site, thereby ensuring smooth aortic flow, improving cardiac function and achieving therapeutic purposes. | Device | Case |
Primary outcome
Cumulative all-cause mortality at 12 months postoperatively
Time frame: 12 months
All-cause death includes cardiac death and non-cardiac death
10 secondary outcomes
Incidence of major adverse cardiovascular events
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Incidence of acute kidney injury
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Incidence of permanent pacemaker implantation
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Incidence of severe vascular complications
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
The incidence of other TAVR-related complications
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Valve function (assessed by echocardiography)
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Change in cardiac function (NYHA)
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Change in cardiac function (NT-proBNP)
Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months
Success rate of devices, calculation method: number of successful devices/total number of cases
Time frame: Perioperative/Periprocedural
Implantation of mechanical circulation assistance device (MCS)
Time frame: Perioperative/Periprocedural
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 7 Aug 2025.
- Background: PubMed 27096593Kodali SK, Thourani VH, Kirtane AJ. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2016 Apr 21;374(16):1591. doi: 10.1056/NEJMc1600179. No abstract available.
- Background: PubMed 26446193Pache G, Schoechlin S, Blanke P, Dorfs S, Jander N, Arepalli CD, Gick M, Buettner HJ, Leipsic J, Langer M, Neumann FJ, Ruile P. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/eurheartj/ehv526. Epub 2015 Oct 7.
- Background: PubMed 25751886Frerker C, Schewel J, Schluter M, Schewel D, Ramadan H, Schmidt T, Thielsen T, Kreidel F, Schlingloff F, Bader R, Wohlmuth P, Schafer U, Kuck KH. Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis. EuroIntervention. 2016 Apr 20;11(13):1530-6. doi: 10.4244/EIJY15M03_03.
- Background: PubMed 31777471Huang H, Kovach CP, Bell S, Reisman M, Aldea G, McCabe JM, Dvir D, Don C. Outcomes of Emergency Transcatheter Aortic Valve Replacement. J Interv Cardiol. 2019 Nov 3;2019:7598581. doi: 10.1155/2019/7598581. eCollection 2019.
- Background: PubMed 28566471Bongiovanni D, Kuhl C, Bleiziffer S, Stecher L, Poch F, Greif M, Mehilli J, Massberg S, Frey N, Lange R, Laugwitz KL, Schymik G, Frank D, Kupatt C. Emergency treatment of decompensated aortic stenosis. Heart. 2018 Jan;104(1):23-29. doi: 10.1136/heartjnl-2016-311037. Epub 2017 May 31.
- Background: PubMed 3421177Block PC, Palacios IF. Clinical and hemodynamic follow-up after percutaneous aortic valvuloplasty in the elderly. Am J Cardiol. 1988 Oct 1;62(10 Pt 1):760-3. doi: 10.1016/0002-9149(88)91218-0.
- Background: PubMed 11288967Buchwald AB, Meyer T, Scholz K, Schorn B, Unterberg C. Efficacy of balloon valvuloplasty in patients with critical aortic stenosis and cardiogenic shock--the role of shock duration. Clin Cardiol. 2001 Mar;24(3):214-8. doi: 10.1002/clc.4960240308.
- Background: PubMed 17015786Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006 Oct 10;114(15):1616-24. doi: 10.1161/CIRCULATIONAHA.106.639450. Epub 2006 Oct 2.
- Background: PubMed 12473543Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
- 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.
- Background: PubMed 19232707Carabello BA, Paulus WJ. Aortic stenosis. Lancet. 2009 Mar 14;373(9667):956-66. doi: 10.1016/S0140-6736(09)60211-7. Epub 2009 Feb 21.
- Background: PubMed 17448426Supino PG, Borer JS, Preibisz J, Bornstein A. The epidemiology of valvular heart disease: a growing public health problem. Heart Fail Clin. 2006 Oct;2(4):379-93. doi: 10.1016/j.hfc.2006.09.010. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Valve Stenosis, run by Qilu Hospital of Shandong University at 1 site 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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Chuanbao Li (+86 18560083097, bao2460@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative all-cause mortality at 12 months postoperatively (time frame: 12 months). 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 NCT07108478, which also lists 12 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 7 Aug 2025.