RecruitingNCT03002272
Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Sponsor
Medstar Health Research Institute
Enrollment
100 participants
Start Date
Feb 20, 2018
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- a) TAVR performed more than 3 years ago
- SAVR performed more than 3 years ago
- Propensity matched to an enrolled TAVR subject
Exclusion Criteria4
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate
- Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
- Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)
Interested in this trial?
Get notified about updates and connect with the research team.
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03002272