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

University of Padova

Status: Unknown

Conditions: Aortic Valve Disease

Treatments: Device: Transcatheter Aortic Valve Implantation

Study type: Observational

Funder types: Other

Identifiers

NCT04647864

CAvEAT

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 4 patient groups

Group 1

Description:

Edwards Sapien 3 and Edwards Sapien 3 Ultra

Treatment:

Device: Transcatheter Aortic Valve Implantation

Group 2

Description:

Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO

Treatment:

Device: Transcatheter Aortic Valve Implantation

Group 3

Description:

Boston Scientific Acurate neo and Boston Scientific Acurate neo2

Treatment:

Device: Transcatheter Aortic Valve Implantation

Group 4

Description:

St. Jude Medical Portico

Treatment:

Device: Transcatheter Aortic Valve Implantation