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

Aortic Valve Disease Clinical Trial

— CAvEAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04647864
• Other study ID #: CAvEAT
• Status: Recruiting
• Start date: January 28, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2021
• Source: University of Padova
• Contact: Matteo Martinato, PhD
• Phone: +390498275646
• Email: matteo.martinato[@]unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• Transcatheter Aortic Valve Implantation
Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.

Locations

Country	Name	City	State
Italy	Azienda Ospedale Università Padova	Padova

Sponsors (2)

Lead Sponsor	Collaborator
University of Padova	Fondazione GISE Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful selective cannulation of both coronary arteries	Successful selective cannulation of both coronary arteries	Immediately after TAVI
Secondary	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
Secondary	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