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

NCT04647864 | Unknown FDA Device

• 1 other identifier: CAvEAT
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• Successful selective cannulation of both coronary arteries

  Successful selective cannulation of both coronary arteries

  Immediately after TAVI

Secondary Outcomes (2)

• Successful selective cannulation of only left coronary artery

  Immediately after TAVI

• Successful selective cannulation of only right coronary artery

  Immediately after TAVI

Study Arms (4)

Group 1

Edwards Sapien 3 and Edwards Sapien 3 Ultra

Device: Transcatheter Aortic Valve Implantation

Group 2

Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO

Device: Transcatheter Aortic Valve Implantation

Group 3

Boston Scientific Acurate neo and Boston Scientific Acurate neo2

Device: Transcatheter Aortic Valve Implantation

Group 4

St. Jude Medical Portico

Device: Transcatheter Aortic Valve Implantation

Interventions

Transcatheter Aortic Valve Implantation DEVICE

Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.

Also known as: Transcatheter Aortic Valve Replacement, Percutaneous aortic valve replacement (PAVR), Percutaneous aortic valve implantation (PAVI)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead
• Fondazione GISE Onlus: collaborator

Study Sites (1)

Azienda Ospedale Università Padova

Padua, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Matteo Martinato, PhD

CONTACT

+390498275646; matteo.martinato@unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 1, 2020
• Study Start: January 28, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

IT (1)