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

Launched by ANNETINE GELIJNS · Sep 10, 2021

Keywords

ClinConnect Summary

This clinical trial, called PRIMARY, is studying two different ways to repair the mitral valve in older adults (those aged 65 and older) who have a condition known as mitral valve regurgitation, where the valve does not close properly, allowing blood to flow backward. The trial compares a less invasive method called transcatheter edge-to-edge repair (TEER) with traditional surgical repair. The aim is to see which method is more effective for treating this condition, especially in patients who may be at different levels of surgical risk. The trial will take place in several countries, including the U.S., Canada, Germany, and the United Kingdom.

To be eligible for this trial, participants must have moderate to severe mitral valve regurgitation and be considered candidates for both TEER and surgical repair based on their heart team's evaluation. Key requirements include being at least 65 years old and able to perform a simple 6-minute walk test. Participants will receive either treatment and will be monitored closely throughout the trial to assess their recovery and overall heart health. It’s important to note that people with certain other health conditions or previous heart surgeries may not qualify for this study.

Gender

ALL

Eligibility 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 ≥65 yrs 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 MV transcatheter edge-to-edge and surgical repair per local heart team assessment
• • Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on the local heart team assessment (see 2020 ACC/AHA guidelines for the management of patients with valvular heart disease)
• • Patients with AF who meet an indication for concomitant ablation may be included provided the local heart team verifies 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 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 meaningful 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 its primary endpoint or that clinically interferes with the present study endpoints.