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

Medstar Health Research Institute100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Aortic Valve Replacement

Interventions

TAVRDEVICE

subjects that underwent TAVR more than 3 years ago

SAVRDEVICE

Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Washington Hospital Center

Washington D.C., District of Columbia, United States

RECRUITING

Outcomes

Primary Outcomes

Prosthetic valve dysfunction

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

Time frame: 7 years

Secondary Outcomes

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

Central Contacts

Megan Rowland, MPH

CONTACT

202-877-2959 megan.e.rowland@medstar.net

Data from ClinicalTrials.gov

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