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

{ "Percutaneous or Surgical Repair for Mitral Prolapse and Regurgitation", "This study is comparing two ways to fix severe mitral regurgitation (a leaky heart valve) in people aged 60 and older. You would receive either a transcatheter edge-to-edge repair (TEER), where a device is inserted through a vein to help the valve close better, or traditional surgery to repair the valve. The study wants to see which method is safer and more effective over the long term. To join, your heart team must agree that both repair options are suitable for you. The study is looking at how well the valve is repaired, hospital stays, and overall health after 3 years. We don't know the current recruitment status.", "design": "This is a randomized study comparing two treatments, with about 450 participants planned. It is an open-label study, meaning both you and your doctors will know which treatment you receive.", "commitments": "You would undergo either a transcatheter edge-to-edge repair or mitral valve surgery. The study will then track your health and valve function for 3 years.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for 3 years after their intervention to assess long-term outcomes.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Active, Not Recruiting

NAAges 60+InterventionalTreatment

Annetine Gelijns

~450 participants

Updated 2026-06-24 on ClinicalTrials.gov

What's tested:Mitral valve repairTranscatheter edge-to-edge repair

At a glance

Recruiting sites

0 of 62 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.

Measured over 3 years post intervention

Conditions

Mitral Valve Regurgitation

Where it's being run

62 sites across 28 states

Germany13

England6

United Kingdom6

California4

New York3

Ontario3

Spain3

Georgia2

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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.

What this trial measures

All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.3 years post intervention
All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention. Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean.

Trialytics