Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry

NCT04031274 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2019-07-24

No results posted yet for this study

Summary

an international multicentre registry designed to answer 3 clinical questions:

1. Describing the characteristics and outcomes of current patients undergoing aortic + mitral transcatheter heart valve procedures.
2. Better understanding of the predictors for MR regression following isolated TAVI and consequently estimating the fraction of patients who will be suitable for TMVR/r post TAVI
3. Examining the clinical outcomes of patients with significant MR post TAVI who subsequently underwent TMVR/r compared to those left for medical management.

Conditions

  • Aortic Stenosis
  • Mitral Regurgitation

Interventions

DEVICE

TAVI

Trascatheter aortic valve implantation

DEVICE

TMVR/r

Transcatheter mitral valve replacement/repair

Sponsors & Collaborators

  • Clinique Pasteur

    collaborator OTHER
  • University of Catania

    collaborator OTHER
  • Montefiore Medical Center

    collaborator OTHER
  • University Medical Centre Ljubljana

    collaborator OTHER
  • University of Bonn

    collaborator OTHER
  • Medical University of Vienna

    collaborator OTHER
  • University Hospital, Antwerp

    collaborator OTHER
  • University of Padova

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • Clinical Institute Saint Ambrogio, Milan

    collaborator UNKNOWN
  • Hospital San Carlos, Madrid

    collaborator OTHER
  • McGill University

    collaborator OTHER
  • Mayo Clinic

    collaborator OTHER
  • IRCCS San Raffaele

    collaborator OTHER
  • IRCCS Policlinico S. Donato

    collaborator OTHER
  • Galway University Hospitals

    collaborator UNKNOWN
  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV
  • University Hospital Freiburg

    collaborator OTHER
  • Hadassah Medical Organization

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    collaborator OTHER
  • Teikyo University

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Cliniche Humanitas Gavazzeni

    collaborator OTHER
  • G. Pasquinucci Heart Hospital, Massa

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Royal Victoria Hospital, Belfast

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • Cardiovascular Center Frankfurt

    collaborator OTHER
  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Ran Kornowski, MD · Rabin Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-09-01
Completion
2020-12-31
FDA Device
Yes

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031274 on ClinicalTrials.gov