Long-term Follow-up of TAVR and SAVR for Aortic Valve Replacement

This study is looking at how well two types of aortic valve replacement procedures, TAVR (Transcatheter Aortic Valve Replacement) and SAVR (Surgical Aortic Valve Replacement), work over a long period. Researchers want to understand the long-term function of these prosthetic (artificial) valves. You might be able to join if you had a TAVR procedure more than three years ago. The study will collect information from your medical records and follow-up visits, including echocardiograms (ultrasound of the heart) to check valve function. The main goal is to see if there is any prosthetic valve dysfunction (problems with the artificial valve) after seven years. This is an observational study, meaning researchers will watch and collect information without giving new treatments. The current status of the study is unclear.

Study design
This is an observational study with a planned enrollment of 100 participants. It compares subjects who underwent TAVR to historical controls who underwent SAVR.
What's involved
The study will collect clinical and procedural data from your original implant/surgery, along with clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed yearly.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, prosthetic valve dysfunction, is measured at 7 years.

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NCT03002272

Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

Recruiting
Not specifiedAges 18+Observational
Medstar Health Research Institute
~100 participants
Updated 2023-05-26 on ClinicalTrials.gov
What's tested:TAVRSAVR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prosthetic valve dysfunction
Measured over 7 years
Aortic Valve Replacement
1 sites across 1 states
District of Columbia1

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  • Prosthetic valve dysfunction7 years

    Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation