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

NCT ID: NCT04647864

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-28

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Edwards Sapien 3 and Edwards Sapien 3 Ultra

Transcatheter Aortic Valve Implantation

Intervention Type DEVICE

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

Group 2

Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO

Transcatheter Aortic Valve Implantation

Intervention Type DEVICE

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

Group 3

Boston Scientific Acurate neo and Boston Scientific Acurate neo2

Transcatheter Aortic Valve Implantation

Intervention Type DEVICE

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

Group 4

St. Jude Medical Portico

Transcatheter Aortic Valve Implantation

Intervention Type DEVICE

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

Interventions

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Transcatheter Aortic Valve Implantation

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

Intervention Type DEVICE

Other Intervention Names

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Transcatheter Aortic Valve Replacement Percutaneous aortic valve replacement (PAVR) Percutaneous aortic valve implantation (PAVI)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione GISE Onlus

OTHER

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedale Università Padova

Padua, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Matteo Martinato, PhD

Role: CONTACT

+390498275646

Facility Contacts

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Giuseppe Tarantini

Role: primary

Other Identifiers

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CAvEAT

Identifier Type: -

Identifier Source: org_study_id

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