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

• Conditions: Aortic Valve Disease
• Interventions: Device: Transcatheter Aortic Valve Implantation

• Registration Number: NCT04647864
• Lead Sponsor: University of Padova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-01
• Study Start: 2021-01-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 4	Transcatheter Aortic Valve Implantation	St. Jude Medical Portico
Group 2	Transcatheter Aortic Valve Implantation	Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO
Group 1	Transcatheter Aortic Valve Implantation	Edwards Sapien 3 and Edwards Sapien 3 Ultra
Group 3	Transcatheter Aortic Valve Implantation	Boston Scientific Acurate neo and Boston Scientific Acurate neo2

Primary Outcome Measures

Name	Time	Method
Successful selective cannulation of both coronary arteries	Immediately after TAVI	Successful selective cannulation of both coronary arteries

Secondary Outcome Measures

Name	Time	Method
Successful selective cannulation of only left coronary artery	Immediately after TAVI	Successful selective cannulation of only left coronary artery (and no cannulation or sub selective cannulation of the contralateral)
Successful selective cannulation of only right coronary artery	Immediately after TAVI	Successful selective cannulation of only right coronary artery (and no cannulation or sub selective cannulation of the contralateral)

Trial Locations

Locations (1)

Azienda Ospedale Università Padova; 🇮🇹 Padova, Italy