Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
ConditionAortic Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedstar Health Research Institute
About this trial
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 criteria
Qualifiers
None
Disqualifiers
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)
Trial design
Treatments tested in this trial
- TAVR
- SAVR
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
1Washington Hospital Center20010, Washington D.C.District of Columbia, United States
Sponsors and collaborators
Medstar Health Research Institute
Lead sponsor
Source ClinicalTrials.gov