Aortic Valve Replacement
Conditions
Brief summary
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.
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.
Interventions
DEVICETAVR
subjects that underwent TAVR more than 3 years ago
DEVICESAVR
Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
Sponsors
Medstar Health Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic valve dysfunction | 7 years | Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional status | discharge from hospital | Change in functional status from baseline and discharge per NYHA classification |
| Increase in severity of aortic regurgitation | upto 7 years | Increase in severity of aortic regurgitation by one or more grading of severity |
Countries
United States
Contacts
Primary ContactMegan Rowland, MPH
Outcome results
None listed