An observational study in Aortic Valve Replacement, sponsored by Medstar Health Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-26.
Sponsored by Medstar Health Research Institute · Observational
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.
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.
Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
This observational study will enroll subjects that underwent TAVR more than 3 years ago. TAVR.
Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
Inclusion criteria for TAVR subjects
a) TAVR performed more than 3 years ago
Exclusion criteria
Inclusion criteria for SAVR subjects
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)
This observational study will enroll subjects that underwent TAVR more than 3 years ago.
Device: TAVR
Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
Device: SAVR
subjects that underwent TAVR more than 3 years ago
Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
Prosthetic valve dysfunction
Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation
Time frame: 7 years
Change in functional status
Change in functional status from baseline and discharge per NYHA classification
Time frame: discharge from hospital
Increase in severity of aortic regurgitation
Increase in severity of aortic regurgitation by one or more grading of severity
Time frame: upto 7 years
Plan to share: No
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Medstar Health Research Institute