Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

May 21, 2026 updated by: Xijing Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Xiangbin Pan, MD, PhD
        • Principal Investigator:
          • Xiangbin Pan, MD, PhD
      • Shanghai, China
        • Recruiting
        • Shanghai Zhongshan Hospital, Fudan University
        • Contact:
          • Lai Wei, MD, PhD
        • Principal Investigator:
          • Lai Wei, MD, PhD
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jian Yang, MD, PhD
        • Sub-Investigator:
          • Meng en Zhai, PhD
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Yingqiang Guo, MD, PhD
        • Principal Investigator:
          • Yingqiang Guo, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young (50~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population

Description

Inclusion Criteria:

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:

    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%.

  • 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.

Exclusion Criteria:

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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
300 retrospectively enrolled patients
Procedure: TAVR
Procedure: 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.
150 prospectively enrolled patients
Procedure: TAVR
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: At 5 years
The primary end point is the 5 year all-cause mortality
At 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annular rupture
Time Frame: At 1 day of discharge
The incidence of annular rupture
At 1 day of discharge
Paravalvular leakage
Time Frame: At 1 day of discharge, 30 days, 1, 3, 5 years
The incidence of paravalvular leakage
At 1 day of discharge, 30 days, 1, 3, 5 years
Technical success
Time Frame: At exit from procedure room

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
At exit from procedure room
Procedural success
Time Frame: At 30 days

Procedural success at 30 days defined as meeting all of the following:

  • Device success

  • No device or procedure related SAE's as follows:

    1. Life-threatening bleed (BARC 3b or greater)
    2. Major vascular or cardiac structural complications requiring unplanned reintervention or surgery
    3. Stage 2 or 3 AKI (includes new dialysis)
    4. MI or need for PCI/CABG
    5. Severe heart failure or hypotension requiring IV inotrope >12 hours, ultrafiltration or mechanical circulatory support
    6. Prolonged intubation > 48 hours
    7. Need for a permanent pacemaker implant or continuous, new onset atrial fibrillation
At 30 days
Mortality (all cause & cardiovascular)
Time Frame: At 30 days, 1, 3, 5 years
The incidence of mortality (all cause & cardiovascular)
At 30 days, 1, 3, 5 years
Stroke (disabling and nondisabling)
Time Frame: At 30 days, 1, 3, 5 years
The incidence of stroke (disabling and nondisabling)
At 30 days, 1, 3, 5 years
Rehospitalization (procedure, valve and heart failure related)
Time Frame: At 30 days, 1, 3, 5 years
The incidence of rehospitalization (procedure, valve and heart failure related)
At 30 days, 1, 3, 5 years
Major vascular complication
Time Frame: At 30 days, 1, 3, 5 years
The incidence of major vascular complication
At 30 days, 1, 3, 5 years
Major or life-threatening bleeding
Time Frame: At 30 days, 1, 3, 5 years
The incidence of major or life-threatening bleeding
At 30 days, 1, 3, 5 years
Myocardial infarction
Time Frame: At 30 days, 1, 3, 5 years
The incidence of myocardial infarction
At 30 days, 1, 3, 5 years
Acute kidney injury stage 2 or 3
Time Frame: At 30 days, 1, 3, 5 years
The incidence of acute kidney injury stage 2 or 3
At 30 days, 1, 3, 5 years
Need for a permanent pacemaker
Time Frame: At 30 days, 1, 3, 5 years
The incidence of permanent pacemaker implantation
At 30 days, 1, 3, 5 years
New onset atrial fibrillation
Time Frame: At 30 days, 1, 3, 5 years
The incidence of new onset atrial fibrillation
At 30 days, 1, 3, 5 years
Valve endocarditis
Time Frame: At 30 days, 1, 3, 5 years
The incidence of valve endocarditis
At 30 days, 1, 3, 5 years
Valve thrombosis
Time Frame: At 30 days, 1, 3, 5 years
The incidence of valve thrombosis
At 30 days, 1, 3, 5 years
New York Heart Association class
Time Frame: At 30 days, 1, 3, 5 years
The changes in New York Heart Association class
At 30 days, 1, 3, 5 years
Patient-prosthesis mismatch
Time Frame: At 30 days, 1, 3, 5 years
The incidence of patient-prosthesis mismatch
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
The changes in Health status as evaluated by Quality of Life questionnaires - KCCQ
At baseline, 30 days, 1, 3, 5 years
The composite of all-cause mortality, stroke and rehospitalization
Time Frame: At 30 days, 1, 3, 5 years
The composite of all-cause mortality, stroke, rehospitalization (procedure, valve and heart failure related) at 30 days, 1, 3, 5 years
At 30 days, 1, 3, 5 years
The composite of device success
Time Frame: At 30 days
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
At 30 days
The durability performance of Sapien 3
Time Frame: At 1, 3, 5 years
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
At 1, 3, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Shanghai Zhongshan Hospital
West China Hospital
Fu Wai Hospital, Beijing, China

Investigators

  • Principal Investigator: Jian Yang, MD, PhD, Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • China Young TAVR Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) would not be shared, according to local authority data privacy policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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