China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

NCT ID: NCT03466918

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2024-06-19

Brief Summary

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Detailed Description

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.

A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

Conditions

Aortic Stenosis; Symptomatic Aortic Stenosis; Aortic Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with SAPIEN 3 THV

Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system

Group Type: EXPERIMENTAL

SAPIEN 3 THV with the Commander delivery system

Intervention Type: DEVICE

Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system

Interventions

SAPIEN 3 THV with the Commander delivery system

Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.

2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.

3. NYHA Functional Class II or greater.

4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.

5. The study patient agrees to comply with all required postprocedure follow-up visits.

Exclusion Criteria

1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.

2. Aortic valve is a congenital unicuspid or is non-calcified.

3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).

4. Anomalous coronary artery that would interfere with proper placement of the valve.

5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Junbo GE

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital and Fudan University

Locations

Fuwai Hospital, CAMS&PUMC

Beijing, , China

WestChina Hospital, Sichuan University

Chengdu, , China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Zhongshan Hospital Fudan University

Shanghai, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-08

Identifier Type: -

Identifier Source: org_study_id