Skip to main content
Clinical Trials/NCT05168826
NCT05168826Active, not recruitingNot Applicable

SAPIEN 3 China Post Market Registry Study

Edwards Lifesciences14 sites in 1 country250 enrolledStarted: January 24, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
250
Locations
14
Primary Endpoint
All-cause mortality

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • All surgical risks as determined by the site Heart Team
  • 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

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

Arms & Interventions

Transcatheter Aortic Valve Implantation (TAVI)

Intervention: SAPIEN 3 Transcatheter Heart Valve (Device)

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: 10 years

The number of patients that died

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Edwards Lifesciences
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (14)

Loading locations...

Identifiers

NCT ID
NCT05168826
Other Study IDs
2021-06

Dates

First Submitted
(4 years ago)
First Posted
(4 years ago)
Primary Completion
(in 9 years)
Study Completion
(in 9 years)
Last Verified
(2 months ago)
Last updated
(last month)

Regulatory & Sharing

FDA Regulated Drug
No
FDA Regulated Device
Yes
IPD Sharing Plan
No
Has Results
No

Similar Trials