Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

Study Overview
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Brief Summary
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In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

Detailed Description
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The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers. Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Official Title
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Evaluation of Clinical Outcomes of Transcatheter Aortic Valve-in-Valve Implantation in Polish Population - Observational Multicenter Registry

Conditions
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Aortic Valve Stenosis, Aortic Valve Insufficiency, Ventricular Outflow Obstruction, Left

Intervention / Treatment
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* Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency Qualification for TAVI by decision of the local Heart Team Patient provided written informed consent

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 |
| --- | --- |
| Transcatheter Aortic Valve-in-Valve Implantation Cohort<br> | Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)<br>* Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses<br>* Other names: Transcatheter Aortic Valve-in-Valve Replacement (ViV-TAVR);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VARC (Valve Academic Research Consortium-2) defined Clinical Efficacy composite endpoint | All-cause mortality All stroke (disabling and non-disabling) Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure NYHA (New York Heart Association) class III or IV functional classification of heart failure Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation | From 30 days post procedure to completion of at least 2 years of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VARC defined 'Device success' composite endpoint | Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis - patient mismatch and mean aortic valve gradient ,20 mmHg or peak velocity ,3 m/s, AND no moderate or severe prosthetic valve regurgitation) | 30 days | 
| VARC defined Early Safety composite endpoint | All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR)) | 30 days | 
| VARC defined Time-related valve safety composite endpoint | Structural valve deterioration Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation) Requiring repeat procedure (TAVI or SAVR) Prosthetic valve endocarditis Prosthetic valve thrombosis Thrombo-embolic events (e.g. stroke) VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma) | From device implant to completion of at least 2 years of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, valve-in-valve, aortic stenosis