China S3 PMS: SAPIEN 3 China Post Market Registry Study

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Aortic Stenosis, Severe

Treatments: Device: SAPIEN 3 Transcatheter Heart Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT05168826

2021-06

Details and patient eligibility

About

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.

Full description

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

Enrollment: 250 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Transcatheter Aortic Valve Implantation (TAVI)

Treatment:

Device: SAPIEN 3 Transcatheter Heart Valve