Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedStudy Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
ExpectedMay 26, 2023
May 1, 2023
5.9 years
December 21, 2016
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Prosthetic valve dysfunction
Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation
7 years
Secondary Outcomes (2)
Change in functional status
discharge from hospital
Increase in severity of aortic regurgitation
upto 7 years
Study Arms (2)
TAVR
This observational study will enroll 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
Interventions
Eligibility Criteria
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
You may qualify if:
- a) TAVR performed more than 3 years ago
You may not qualify if:
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate
- Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
- Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)
- SAVR performed more than 3 years ago
- Propensity matched to an enrolled TAVR subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2016
First Posted
December 23, 2016
Study Start
February 20, 2018
Primary Completion
January 1, 2024
Study Completion (Estimated)
January 1, 2028
Last Updated
May 26, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share