China S3 PMS: SAPIEN 3 China Post Market Registry Study

SAPIEN 3 China Post Market Registry Study

The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis, Severe
• Intervention / Treatment: Device: SAPIEN 3 Transcatheter Heart Valve

Detailed Description

This is an observational, single-arm, multicentre, post-market study.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Edwards THV Clinical Affairs; Phone Number: 949-250-2500; Email: THV_CT.gov@Edwards.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Peking University Third Hospital
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Recruiting
      • Xiamen Cardiovascular Hospital Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • First affiliated Hospital of Sun Yat-Sen University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Provincial Chest Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • The Second Xiangya Hospital of Central South University
  • Shangahi
    • Shanghai, Shangahi, China, 200000
      • Recruiting
      • Shanghai General Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Chest Hospital
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Xi'an, Shanxi, China, 710000
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiao Tong University
  • Xinjiang Province
    • Ürümqi, Xinjiang Province, China, 830000
      • Recruiting
      • First Affiliated Hospital of Xinjiang Medical University
    • Ürümqi, Xinjiang Province, China, 830000
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who will undergo TAVI with the Edwards SAPIEN 3 System.

Description

Inclusion Criteria:

1. Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
2. All surgical risks as determined by the site Heart Team
3. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
2. Considered to be part of a vulnerable population
3. Pre-existing mechanical or bioprosthetic aortic valve
4. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
5. Cannot tolerate an anticoagulation/antiplatelet regimen
6. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
7. Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
8. Participating in a drug or device study that has not reached its primary endpoint

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transcatheter Aortic Valve Implantation (TAVI)	Device: SAPIEN 3 Transcatheter Heart Valve; Implantation of the SAPIEN 3 valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	The number of patients that died	10 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Heart disease; Transcatheter aortic valve implantation (TAVI); Transcatheter aortic valve replacement (TAVR); SAPIEN 3
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2021-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes