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
Study Sites (14)
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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
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