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

Purpose

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.

Condition

  • Aortic Valve Replacement

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
TAVR This observational study will enroll subjects that underwent TAVR more than 3 years ago.
  • Device: TAVR
    subjects that underwent TAVR more than 3 years ago
SAVR Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
  • Device: SAVR
    Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Recruiting Locations

Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Megan Rowland
202-877-2959
megan.e.rowland@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Megan Rowland, MPH
202-877-2959
megan.e.rowland@medstar.net

Detailed 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.