Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Prosthetic valve dysfunction [7 years]
Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation
Secondary Outcome Measures
- Change in functional status [discharge from hospital]
Change in functional status from baseline and discharge per NYHA classification
- Increase in severity of aortic regurgitation [upto 7 years]
Increase in severity of aortic regurgitation by one or more grading of severity
Eligibility Criteria
Criteria
Inclusion criteria for TAVR subjects
- TAVR performed more than 3 years ago
Exclusion criteria
-
Subjects unable to consent to participate, unless the subject has a legally authorized representative
-
Subjects unwilling to participate
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Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
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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
-
SAVR performed more than 3 years ago
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
Sponsors and Collaborators
- Medstar Health Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAVR Durability