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

NCT03466918 | Completed Results DMC FDA Device

• 1 other identifier: 2017-08
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Aortic Stenosis; Symptomatic Aortic Stenosis; Aortic Regurgitation

Keywords

TAVI; TAVR; CHINA; SAPIEN 3; High Risk; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  All of the deaths that occurred in this population regardless of the cause.

  30-days

Secondary Outcomes (3)

• Cardiovascular Mortality

  30-days

• Non-Cardiovascular Mortality

  30-days

• Number of Participants With a Stroke

  30-days

Study Arms (1)

Patients with SAPIEN 3 THV

EXPERIMENTAL

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

Device: SAPIEN 3 THV with the Commander delivery system

Interventions

SAPIEN 3 THV with the Commander delivery system DEVICE

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

Patients with SAPIEN 3 THV

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• NYHA Functional Class II or greater.
• 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.
• The study patient agrees to comply with all required postprocedure follow-up visits.

You may not qualify if:

• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
• Aortic valve is a congenital unicuspid or is non-calcified.
• 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).
• Anomalous coronary artery that would interfere with proper placement of the valve.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (4)

Fuwai Hospital, CAMS&PUMC

Beijing, China

Location

WestChina Hospital, Sichuan University

Chengdu, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Research
• Organization: Edwards Lifesciences

THV_CT.gov@edwards.com

949-250-2500

Study Officials

• Prof Junbo GE

  Zhongshan Hospital and Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 15, 2018
• Study Start: May 23, 2018
• Primary Completion: July 3, 2019
• Study Completion: June 19, 2024
• Last Updated: September 10, 2025
• Results First Posted: July 15, 2020

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)