Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

MedStar Health

Status: Enrolling

Conditions: Aortic Valve Replacement

Treatments: Device: TAVR; Device: SAVR

Study type: Observational

Funder types: Other

Identifiers

NCT03002272

TAVR Durability

Details and patient eligibility

About

In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.

Full description

There is limited available information on long term TAVR valve function. In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for TAVR subjects

a) TAVR performed more than 3 years ago

Exclusion criteria

1. Subjects unable to consent to participate, unless the subject has a legally authorized representative
2. Subjects unwilling to participate
3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Inclusion criteria for SAVR subjects

1. SAVR performed more than 3 years ago
2. Propensity matched to an enrolled TAVR subject

Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Trial design

100 participants in 2 patient groups

TAVR

Description:

This observational study will enroll subjects that underwent TAVR more than 3 years ago.

Treatment:

Device: TAVR

SAVR

Description:

Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Treatment:

Device: SAVR