Aortic StenosisASCENTNCT07450196
A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China
An observational study of Aortic Stenosis and AORTIC VALVE DISEASES, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Stenosis, AORTIC VALVE DISEASES
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 31 Aug 2029
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: severe symptomatic aortic valve stenosis (AS) patients with type-0 bicuspid anatomy
Who may be able to join
- Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.
- 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%.
- Type-0 bicuspid aortic valve anatomy confirmed by multi-detector computed tomography (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 provided written informed consent.
Who cannot join
- Challenging calcification based on physician's experience and discretion
- Aortic valve is a congenital unicuspid valve, congenital Type-1 or Type-2 bicuspid valve, tricuspid or quadricuspid valve
- Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR
- Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease)
- 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
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- Emergency interventional/surgical procedures within 30 days of the valve implant procedure
- Hypertrophic cardiomyopathy with obstruction
- Ventricular dysfunction with LVEF < 30%
- Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation
- Renal replacement therapy at the time of screening
- Estimated life expectancy < 12 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Beijing, Beijing Municipality, 100037
Xiangbin Pan, MD.PhD, +8688396666, panxiangbin@fuwaihospital.org
panxiangbin@fuwaihospital.org
About this study
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.
- Conditions
- Aortic Stenosis, AORTIC VALVE DISEASES
- Being tested
- Transcatheter Aortic Valve Replacement
- Keywords
- Balloon-expandable transcatheter heart valve, TAVR, aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementDevice
Also called TAVR
Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.
| Study group | Role | What they receive |
|---|---|---|
| patients with Type-0 bicuspid aortic stenosis | patients with severe, calcific aortic stenosis and with Type-0 bicuspid anatomy confirmed by MDCT. Receives: Device: Transcatheter Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
Measured: At 1 year after procedure
Secondary outcomes (21)
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
Measured: At 30 days after procedure
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, and less than moderate aortic regurgitation), according to the VARC-3 definition
Measured: At 30 days after procedure
Annular rupture
Annular rupture
Measured: At discharge(assessed up to 30 days)
Paravalvular leakage
Paravalvular leakage
Measured: At discharge (assessed up to 30 days) , 30 days, 1year
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 atrial fibrillation
Measured: At 30 days
Mortality (all cause & cardiovascular)
Mortality (all cause \& cardiovascular)
Measured: At 30 days,1year
Stroke (disabling and nondisabling)
Stroke (disabling and nondisabling)
Measured: At 30 days, 1year
Rehospitalization (procedure, valve and heart failure related)
Rehospitalization (procedure, valve and heart failure related)
Measured: At 30 days, 1year
Major vascular complication
Major vascular complication
Measured: At 30 days, 1year
Major or life-threatening bleeding
Major or life-threatening bleeding
Measured: At 30 days, 1year
Myocardial infarction
Myocardial infarction
Measured: At 30 days, 1year
Acute kidney injury stage 2 or 3
Acute kidney injury stage 2 or 3
Measured: At 30 days, 1year
Need for a permanent pacemaker
Need for a permanent pacemaker
Measured: At 30 days, 1year
New onset atrial fibrillation
New onset atrial fibrillation
Measured: At 30 days, 1year
Valve endocarditis
Valve endocarditis
Measured: At 30 days, 1year
Valve thrombosis
Valve thrombosis
Measured: At 30 days, 1year
New York Heart Association class
New York Heart Association class
Measured: At 30 days, 1year
Patient-prosthesis mismatch
Patient-prosthesis mismatch
Measured: At 30 days, 1year
Index hospitalization days
Index hospitalization days
Measured: At discharge (assessed up to 30 days)
Health status as evaluated by Quality of Life questionnaires - KCCQ
Health status as evaluated by Quality of Life questionnaires - KCCQ
Measured: At baseline, 30 days, 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450196
- Sponsor's protocol ID
- 2026-3064
- Acronym
- ASCENT
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No