Long-term follow-up on aortic valve replacement function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather long-term data on the function of transcatheter aortic valves (TAVR) and surgical aortic valves (SAVR) in patients who underwent these procedures more than three years ago. Investigators will collect clinical and procedural data from the initial implant or surgery, as well as clinical and echocardiographic data from follow-up visits. Yearly echocardiography assessments will be performed and analyzed in a Core Lab to evaluate valve function over time.

Why it matters

Who can join: the full rules

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 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)

Where it's running

• Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Megan Rowland, MPH
• Email: megan.e.rowland@medstar.net
• Phone: 202-877-2959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.