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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Valve Replacement

Intervention / Treatment
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* Device: TAVR
* Device: SAVR


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for TAVR subjects a) 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 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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR<br>This observational study will enroll subjects that underwent TAVR more than 3 years ago. | Device: TAVR<br>* subjects that underwent TAVR more than 3 years ago<br>|
| SAVR<br>Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago | Device: SAVR<br>* Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago<br>|

What is the study measuring?
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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 |