RECRUITING

PRIMARY Ancillary Substudy

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Conditions

Mitral Valve ProlapseLeft Ventricular FibrosisVentricular ArrhythmiasMitral valve repair (MVr)Transcatheter-edge-to-edge-repair (TEER)Cardiac magnetic resonance imaging (CMR)ZioPatch monitoringHeart biopsy

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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

The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.

Official Title

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy

Quick Facts

Study Start:2023-10-16
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07103733

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:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.
  2. * For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.
  1. * Severe claustrophobia not controlled with sedation.
  2. * Prior adverse reaction to gadolinium administration.
  3. * Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.
  4. * Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).

Contacts and Locations

Study Contact

Chari Ponder, RN, BSN
CONTACT
(646) 899-8106
chari.ponder@mountsinai.org
Jonathan Hupf
CONTACT
(646) 385-0854
Jonathan.Hupf@mountsinai.org

Principal Investigator

Joanna Chikwe, MD
STUDY_DIRECTOR
Cedars-Sinai
Martin Leon, MD
STUDY_DIRECTOR
Columbia University

Study Locations (Sites)

Keck Hospital of the University of Southern California
Los Angeles, California, 90033
United States
Cedars-Sinai
Los Angeles, California, 90048
United States
University of California San Francisco
San Francisco, California, 94143
United States
Stanford University
Stanford, California, 94305
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Maine Medical Center
Portland, Maine, 04102
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109
United States
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, 64111
United States
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, 10065
United States
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
New York, New York, 10075
United States
Duke University Hospital
Durham, North Carolina, 27710
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908
United States
West Virginia University Hospital
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Annetine Gelijns

  • Joanna Chikwe, MD, STUDY_DIRECTOR, Cedars-Sinai
  • Martin Leon, MD, STUDY_DIRECTOR, Columbia University

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 Date2023-10-16
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Mitral valve repair (MVr)
  • Transcatheter-edge-to-edge-repair (TEER)
  • Cardiac magnetic resonance imaging (CMR)
  • ZioPatch monitoring
  • Heart biopsy

Additional Relevant MeSH Terms

  • Mitral Valve Prolapse
  • Left Ventricular Fibrosis
  • Ventricular Arrhythmias