The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI

Study Overview
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Brief Summary
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The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is a significant difference among different type of transcatheter valves in selective coronary cannulation.

Official Title
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The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation) candidate to TAVI according to local Heart Team evaluation, including valve-in-valve procedure due to degeneration of a previously implanted surgical bioprosthesis, who undergo coronary access in the same session of TAVI, immediately after transcatheter valve deployment (the procedures have to be consecutive); Provision of signed informed consent; Age ≥18 Years. Exclusion Criteria: Chronic Kidney Disease stage IV-V (without dialytic treatment; otherwise, patients in dialytic treatment could be included); Current participation in an interventional clinical study; Age < 18 years.

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 |
| --- | --- |
| Group 1<br>Edwards Sapien 3 and Edwards Sapien 3 Ultra | Device: Transcatheter Aortic Valve Implantation<br>* Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.<br>* Other names: Percutaneous aortic valve implantation (PAVI);|
| Group 2<br>Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO | Device: Transcatheter Aortic Valve Implantation<br>* Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.<br>* Other names: Percutaneous aortic valve implantation (PAVI);|
| Group 3<br>Boston Scientific Acurate neo and Boston Scientific Acurate neo2 | Device: Transcatheter Aortic Valve Implantation<br>* Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.<br>* Other names: Percutaneous aortic valve implantation (PAVI);|
| Group 4<br>St. Jude Medical Portico | Device: Transcatheter Aortic Valve Implantation<br>* Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.<br>* Other names: Percutaneous aortic valve implantation (PAVI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful selective cannulation of both coronary arteries | Successful selective cannulation of both coronary arteries | Immediately after TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful selective cannulation of only left coronary artery | Successful selective cannulation of only left coronary artery (and no cannulation or sub selective cannulation of the contralateral) | Immediately after TAVI | 
| Successful selective cannulation of only right coronary artery | Successful selective cannulation of only right coronary artery (and no cannulation or sub selective cannulation of the contralateral) | Immediately after TAVI |