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

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2030-11-15

Brief Summary

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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.

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PRIMARY Ancillary Substudy

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Detailed Description

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The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER compared with surgical repair in patients with primary, degenerative MR. The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations/urgent care visits, valve re-interventions, and quality of life). The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation. This study is closely integrated with the PRIMARY Ancillary Substudy (NCT07103733)

The patient population for this trial consists of adult patients with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible.

Because the use of the commercial edge-to-edge mitral repair device in the U.S. is approved only in patients considered to be at prohibitive risk of MV surgery by a heart team, use of such devices in this trial is considered investigational by the FDA. As such, this trial will be conducted under an Investigational Device Exemption (IDE).

Outcomes will be measured from randomization over a period of 5 years post intervention. The estimated enrollment period is 36 months, and all patients will be followed from randomization for up to 10 years post intervention for particular endpoints. Long-term follow-up will include leveraging administrative datasets linked to clinical trial data.

Conditions

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Mitral Valve Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible and consented patients will be randomized 1:1 to a TEER versus surgical repair. Patient randomization will be stratified by clinical site and by surgical risk profile, namely low, intermediate, and high surgical risk. Primary effectiveness will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignment at randomization whether or not they actually received the treatment to which they were assigned.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery.

Group Type ACTIVE_COMPARATOR

Mitral valve repair

Intervention Type PROCEDURE

Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.

Transcatheter edge-to-edge repair

In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.

Group Type ACTIVE_COMPARATOR

Transcatheter edge-to-edge repair

Intervention Type DEVICE

Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.

Interventions

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Mitral valve repair

Intervention Type PROCEDURE

Transcatheter edge-to-edge repair

Intervention Type DEVICE

Other Intervention Names

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Mitral valve surgery TEER

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Annetine Gelijns

Chair, Department of Population Health Science & Policy Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joanna Chikwe, MD

Role: STUDY_DIRECTOR

Cedars Sinai

Martin Leon, MD

Role: STUDY_DIRECTOR

Columbia University

Patrick O'Gara, MD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

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United States Canada Germany Spain United Kingdom

Central Contacts

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Chari Ponder, RN, BSN

Role: CONTACT

[email protected]

(646) 899-8106

Role: primary

[email protected]

Other Identifiers

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5U01HL088942

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-21-01246

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

PRIMARY Ancillary Substudy

Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery

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Detailed Description

Conditions

Study Design

Study Groups

Surgical mitral valve repair

Mitral valve repair

Transcatheter edge-to-edge repair

Transcatheter edge-to-edge repair

Interventions

Mitral valve repair

Transcatheter edge-to-edge repair

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

Annetine Gelijns

Responsible Party

Annetine Gelijns

Principal Investigators

Joanna Chikwe, MD

Martin Leon, MD

Patrick O'Gara, MD

Locations

Keck Hospital of the University of Southern California

Cedars Sinai Medical Center

University of California San Francisco

Stanford University

Piedmont Heart Institute

Emory University

Ochsner Clinic

Maine Medical Center

The Johns Hopkins Hospital

Massachusetts General Hospital

Brigham and Women's

University of Michigan Hospital

Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons

Dartmouth Hitchcock Medical Center

New York-Presbyterian/Columbia University Medical Center

Weill Cornell Medicine/ New York-Presbyterian Hospital

Northwell Health

Duke University Hospital

Cleveland Clinic

Hospital of the University of Pennsylvania

Medical University of South Carolina

Baylor, Scott and White

University of Virginia Medical Center

West Virginia University Hospital

University of British Columbia, Providence Health Care, St. Paul's Hospital

London Health Sciences

University of Ottawa Heart Institute

Unity Health Toronto (St. Michael's Hospital)

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)

Universitätsklinikum Köln

Herz- und Diabeteszentrum NRW

Kerckhoff Klinik Bad Nauheim

Schüchtermann-Klinik Bad Rothenfelde

Deutsches Herzzentrum der Charité

Universitätsklinikum Frankfurt

Universitätsklinikum Freiburg

Asklepios Klinik St. Georg Hamburg

Universitätsklinikum Hamburg Eppendorf

Universitätsklinikum Heidelberg

Universitätsklinikum Jena

Universitätsklinikum Schleswig-Holstein Campus Kiel

Herzzentrum Leipzig

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Deutsches Herzzentrum München

Hospital Alvaro Cunqueiro