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
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 - collaborator OTHER
-
Clinical Institute Saint Ambrogio, Milan
collaborator UNKNOWN -
Hospital San Carlos, Madrid
collaborator OTHER - collaborator OTHER
- 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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