SAPIEN 3 Ultra EU PMS

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Stenosis

Treatments: Device: Transcatheter Aortic Valve Implantation (TAVI)

Study type: Observational

Funder types: Industry

Identifiers

NCT04860752

2020-02

Details and patient eligibility

About

This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

Full description

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

Enrollment: 500 patients

Sex: All

Ages: Under 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
2. Less than 80 years of age at time of the procedure
3. Low surgical risk
4. Meets clinical and procedural requirements for early discharge
5. 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. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
4. Cannot tolerate an anticoagulation/antiplatelet regimen
5. Active bacterial endocarditis
6. Participating in a drug or device study that has not reached its primary endpoint

Trial design