RECRUITING

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

Conditions

Mitral Valve Regurgitation surgical mitral valve repair transcatheter edge-to-edge repair

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Study Overview

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Description

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

Official Title

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

Quick Facts

Study Start:2022-02-21

Study Completion:2030-11-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05051033

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 Criteria	Exclusion Criteria
* Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography * Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification * Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC/AHA 2020 guidelines for the management of patients with valvular heart disease) * Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation. * Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument	* Non-degenerative types of primary MR (e.g., cleft leaflet) * Secondary or functional MR * Hypertrophic obstructive cardiomyopathy * Presence of an IVC filter or permanent pacing/ICD leads that would interfere with TEER per local heart team assessment * Known allergic reactions to intravenous contrast * Febrile illness within 30-days prior to randomization * Any absolute contraindication to transesophageal echocardiography * Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia * Patients with CAD requiring revascularization * Any prior mitral valve intervention or any prior repair of atrial septal defect * Any prior MV intervention or any prior repair of atrial septal defect * Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery * Need for any emergency intervention or surgery * Active endocarditis * Hemodynamic instability defined as cardiac index \<2.0 l/min/m2 or systolic blood pressure \<90mmHg or need for inotropic support or any mechanical circulatory support * Left ventricular ejection fraction \<25% * Intracardiac mass or thrombus * Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely * Active substance abuse * Suspected inability to adhere to follow-up * Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.

Inclusion Criteria

Exclusion Criteria

* Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography
* Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification
* Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC/AHA 2020 guidelines for the management of patients with valvular heart disease)
* Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation.
* Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument

* Non-degenerative types of primary MR (e.g., cleft leaflet)
* Secondary or functional MR
* Hypertrophic obstructive cardiomyopathy
* Presence of an IVC filter or permanent pacing/ICD leads that would interfere with TEER per local heart team assessment
* Known allergic reactions to intravenous contrast
* Febrile illness within 30-days prior to randomization
* Any absolute contraindication to transesophageal echocardiography
* Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia
* Patients with CAD requiring revascularization
* Any prior mitral valve intervention or any prior repair of atrial septal defect
* Any prior MV intervention or any prior repair of atrial septal defect
* Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery
* Need for any emergency intervention or surgery
* Active endocarditis
* Hemodynamic instability defined as cardiac index \<2.0 l/min/m2 or systolic blood pressure \<90mmHg or need for inotropic support or any mechanical circulatory support
* Left ventricular ejection fraction \<25%
* Intracardiac mass or thrombus
* Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely
* Active substance abuse
* Suspected inability to adhere to follow-up
* Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.

Contacts and Locations

Study Contact

Chari Ponder, RN, BSN

CONTACT

(646) 899-8106

chari.ponder@mountsinai.org

Principal Investigator

Joanna Chikwe, MD

STUDY_DIRECTOR

Cedars Sinai

Martin Leon, MD

STUDY_DIRECTOR

Columbia University

Patrick O'Gara, MD

STUDY_DIRECTOR

Brigham and Women's Hospital

Study Locations (Sites)

Keck Hospital of the University of Southern California

Los Angeles, California, 90033

United States

Cedars Sinai Medical Center

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

Emory University

Atlanta, Georgia, 30322

United States

Ochsner Clinic

New Orleans, Louisiana, 70121

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

Brigham and Women's

Boston, Massachusetts, 02115

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

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032

United States

Weill Cornell Medicine/ New York-Presbyterian Hospital

New York, New York, 10065

United States

Northwell Health

New York, New York, 21287

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Baylor, Scott and White

Dallas, Texas, 75246

United States

University of Virginia Medical Center

Charlottesville, Virginia, 22903

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
Patrick O'Gara, MD, STUDY_DIRECTOR, Brigham and Women's Hospital

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 Date2022-02-21

Study Completion Date2030-11-15

Study Record Updates

Study Start Date2022-02-21

Study Completion Date2030-11-15

Terms related to this study

Keywords Provided by Researchers

surgical mitral valve repair
transcatheter edge-to-edge repair

Additional Relevant MeSH Terms

Mitral Valve Regurgitation