Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Replacement
- Sponsor
- Medstar Health Research Institute
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Prosthetic valve dysfunction
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prosthetic valve dysfunction
Time Frame: 7 years
Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation
Secondary Outcomes
- Increase in severity of aortic regurgitation(upto 7 years)
- Change in functional status(discharge from hospital)