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

NCT07450196 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2026-3064
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Stenosis; AORTIC VALVE DISEASES

Keywords

Balloon-expandable transcatheter heart valve; TAVR; aortic stenosis

Outcome Measures

Primary Outcomes (1)

• The composite of all-cause mortality, stroke, or rehospitalization

  The composite of all-cause mortality, stroke, or rehospitalization

  At 1 year after procedure

Secondary Outcomes (21)

• The composite of all-cause mortality, stroke, or rehospitalization

  At 30 days after procedure

• The composite of device success

  At 30 days after procedure

• Annular rupture

  At discharge(assessed up to 30 days)

• Paravalvular leakage

  At discharge (assessed up to 30 days) , 30 days, 1year

• Technical success

  At exit from procedure room

Study Arms (1)

patients with Type-0 bicuspid aortic stenosis

patients with severe, calcific aortic stenosis and with Type-0 bicuspid anatomy confirmed by MDCT.

Device: Transcatheter Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve Replacement DEVICE

Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.

Also known as: TAVR

patients with Type-0 bicuspid aortic stenosis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

severe symptomatic aortic valve stenosis (AS) patients with type-0 bicuspid anatomy

You may qualify if:

• Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.
• Severe AS, defined as follows:
• a) 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.: collaborator

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Xiangbin Pan

  Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangbin Pan, MD,PhD

CONTACT

+8688396666; panxiangbin@fuwaihospital.org

Ning Zhou

CONTACT

+8688396666; fwzhouning@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)