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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Matteo Martinato, PhD; Phone Number: +390498275646; Email: matteo.martinato@unipd.it

Study Locations

• Italy
  • Padova, Italy
    • Recruiting
    • Azienda Ospedale Universita Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation), who are candidate to TAVI according to local Heart Team evaluation. Valve-in-valve procedure due to degeneration of a previously implanted surgical bio prosthesis are also included in this study population.

All consecutive patients who undergo coronary access immediately after TAVI will be enrolled in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Edwards Sapien 3 and Edwards Sapien 3 Ultra	Device: Transcatheter Aortic Valve Implantation; Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.; Other Names: Transcatheter Aortic Valve Replacement; Percutaneous aortic valve replacement (PAVR); Percutaneous aortic valve implantation (PAVI)
Group 2; Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO	Device: Transcatheter Aortic Valve Implantation; Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.; Other Names: Transcatheter Aortic Valve Replacement; Percutaneous aortic valve replacement (PAVR); Percutaneous aortic valve implantation (PAVI)
Group 3; Boston Scientific Acurate neo and Boston Scientific Acurate neo2	Device: Transcatheter Aortic Valve Implantation; Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.; Other Names: Transcatheter Aortic Valve Replacement; Percutaneous aortic valve replacement (PAVR); Percutaneous aortic valve implantation (PAVI)
Group 4; St. Jude Medical Portico	Device: Transcatheter Aortic Valve Implantation; Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.; Other Names: Transcatheter Aortic Valve Replacement; Percutaneous aortic valve replacement (PAVR); Percutaneous aortic valve implantation (PAVI)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Fondazione GISE Onlus

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (ACTUAL): December 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CAvEAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes