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

Trial ID or NCT#

NCT05051033

Status

recruiting iconRECRUITING

Purpose

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 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)

Eligibility Criteria

Ages Eligible for Study: Older than 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Jack Boyd
Jack Boyd
Cardiac surgeon, Cardiothoracic surgeon, Heart transplant surgeon, Heart and lung transplant surgeon, Vascular surgeon, Cardiovascular surgeon, Lung transplant surgeon
Clinical Associate Professor, Cardiothoracic Surgery
Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology

View on ClinicalTrials.gov