RECRUITING

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Official Title

Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

Quick Facts

Study Start:2020-11-01
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04688190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * clinically significant mitral insufficiency
  2. * patient underwent screening for TMVI
  3. * echocardiography data at baseline (and after TMVI, E2E and surgery)
  4. * follow-up of at least 30 days
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sebastian Ludwig, MD
CONTACT
+4915222816168
se.ludwig@uke.de
Walid Ben Ali, MD
CONTACT
+15145611037
dr.walidbenali@gmail.com

Principal Investigator

Lenard Conradi, MD
PRINCIPAL_INVESTIGATOR
University Heart and Vascular Center Hamburg
Thomas Modine, MD
PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Sebastian Ludwig, MD
PRINCIPAL_INVESTIGATOR
University Heart and Vascular Center Hamburg
Walid Ben Ali, MD
PRINCIPAL_INVESTIGATOR
Montreal Heart Institute
Alison Duncan, MD
PRINCIPAL_INVESTIGATOR
Royal Brompton Hospital London
Gilbert Tang, MD
PRINCIPAL_INVESTIGATOR
Mount Sinai Medical Center, NYC
Juan F Granada, MD
PRINCIPAL_INVESTIGATOR
Cardiovascular Research Foundation, New York, USA

Study Locations (Sites)

Cedars-Sinai Medical Center, Los Angeles
Los Angeles, California, 90048
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Universitätsklinikum Hamburg-Eppendorf

  • Lenard Conradi, MD, PRINCIPAL_INVESTIGATOR, University Heart and Vascular Center Hamburg
  • Thomas Modine, MD, PRINCIPAL_INVESTIGATOR, University Hospital, Bordeaux
  • Sebastian Ludwig, MD, PRINCIPAL_INVESTIGATOR, University Heart and Vascular Center Hamburg
  • Walid Ben Ali, MD, PRINCIPAL_INVESTIGATOR, Montreal Heart Institute
  • Alison Duncan, MD, PRINCIPAL_INVESTIGATOR, Royal Brompton Hospital London
  • Gilbert Tang, MD, PRINCIPAL_INVESTIGATOR, Mount Sinai Medical Center, NYC
  • Juan F Granada, MD, PRINCIPAL_INVESTIGATOR, Cardiovascular Research Foundation, New York, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-01
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2020-11-01
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Mitral Regurgitation