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

Sponsor
University of Padova (Other)
Overall Status
Recruiting
CT.gov ID
NCT04647864
Collaborator
Fondazione GISE Onlus (Other)
600
Enrollment
1
Location
22.1
Anticipated Duration (Months)
27.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcatheter Aortic Valve Implantation

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI
Actual Study Start Date :
Jan 28, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Successful selective cannulation of both coronary arteries [Immediately after TAVI]

      Successful selective cannulation of both coronary arteries

    Secondary Outcome Measures

    1. 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)

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedale Università Padova Padova Italy

    Sponsors and Collaborators

    • University of Padova
    • Fondazione GISE Onlus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Padova
    ClinicalTrials.gov Identifier:
    NCT04647864
    Other Study ID Numbers:
    • CAvEAT
    First Posted:
    Dec 1, 2020
    Last Update Posted:
    Jul 16, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Aortic Valve Disease

    Study Results

    No Results Posted as of Jul 16, 2021