Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
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(s) | Aortic Valve Replacement |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medstar Health Research Institute |
| Locations | Washington D.C., District of Columbia, United States |
| Start date | 2018-02-20 |
| NCT ID | NCT03002272 |
| Official listing | https://clinicaltrials.gov/study/NCT03002272 |