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

Summary

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.

Eligibility

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.

Conditions2

Locations24 sites

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