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Comparing two methods for repairing mitral valve issues in older adults

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

Not applicable Interventional Icahn School of Medicine at Mount Sinai · NCT05051033

This study is testing whether a less invasive heart valve repair method works as well as traditional surgery for older adults with mitral valve problems.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment450 (estimated)
Ages60 Years and up
SexAll
SponsorIcahn School of Medicine at Mount Sinai Academic / other
Locations61 sites (Los Angeles, California and 60 other locations)
Trial IDNCT05051033 on ClinicalTrials.gov

What this trial studies

This trial is a multicenter, open-label, randomized comparison of transcatheter edge-to-edge repair (TEER) versus surgical repair for patients aged 60 and older with primary degenerative mitral regurgitation (MR). The study aims to evaluate the long-term effectiveness and safety of both interventions, while also analyzing the relationship between MR correction adequacy and clinical outcomes over five years. It includes a diverse patient population across various surgical risk levels, ensuring that both repair strategies are anatomically feasible for participants. The trial will utilize commercially available devices for TEER that are legally marketed in the respective countries involved.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 and older with moderately-severe to severe primary degenerative MR who are deemed suitable for both TEER and surgical repair.

Not a fit: Patients who do not have severe primary degenerative MR or those for whom neither repair strategy is anatomically feasible may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive option for mitral valve repair, improving outcomes and quality of life for older patients with severe MR.

How similar studies have performed: Other studies have shown promising results with transcatheter approaches for mitral valve repair, indicating potential success for this trial's methodology.

Eligibility criteria

Show full inclusion / exclusion criteria 
The patient population for this trial consists of adults 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. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity.

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.

Where this trial is running

Los Angeles, California and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral Valve Regurgitationsurgical mitral valve repairtranscatheter edge-to-edge repair
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.