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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Device: TAVR; Device: SAVR

Detailed Description

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 (Estimated): 100

Contacts and Locations

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

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Washington Hospital Center
      • Contact: Megan Rowland; Phone Number: 202-877-2959; Email: megan.e.rowland@medstar.net
      • Principal Investigator: Ron Waksman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAVR; This observational study will enroll subjects that underwent TAVR more than 3 years ago.	Device: TAVR; subjects that underwent TAVR more than 3 years ago
SAVR; Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago	Device: SAVR; Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic valve dysfunction	Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional status	Change in functional status from baseline and discharge per NYHA classification	discharge from hospital
Increase in severity of aortic regurgitation	Increase in severity of aortic regurgitation by one or more grading of severity	upto 7 years

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimated): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TAVR Durability

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO