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

PRIMARY 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 is being conducted in the U.S., Canada, Germany and the United Kingdom, and is designed as a strategy trial, with all devices legally marketed for use in a particular country eligible to be used.

The primary aim of this study is to evaluate the long-term effectiveness and safety of MV transcatheter edge-to-edge repair compared with surgical repair in patients with primary, degenerative mitral regurgitation.

The secondary aim of the trial is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations/urgent visits, valve re-interventions, and quality of life).

The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation.

The patient population for this trial consists of adult patients 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.

All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity.

To learn more about this clinical trial, please email: Chari Ponder (Chari.Ponder@mountsinai.org)

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

PACeS is a prospective, multicenter, open-label, randomized trial comparing oral anticoagulation with no oral anticoagulation (1:1 ratio) in patients who develop new-onset post-operative atrial fibrillation after isolated coronary artery bypass graft (CABG) surgery.

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation after isolated CABG surgery.

Patients will need to be randomized within 7 days after the qualifying atrial fibrillation event or by hospital discharge, whichever comes first.

To learn more about this clinical trial, please email: Jonathan Hupf (Jonathan.Hupf@mountsinai.org)

Embolic Protection in Patients Undergoing High-Risk Valve Surgery (EMPRO)

EMPRO is a prospective, multi-center, randomized effectiveness trial in high-risk valve surgery patients

The primary objective of this trial is to determine the effectiveness and safety of an embolic protection device compared to a standard aortic cannula to reduce death, clinical stroke, delirium and acute kidney injury in high-risk valve surgery patients.

A secondary objective is to assess the impact of embolic protection on neuro-cognition and functional status.

Eligible patients are those scheduled for high-risk valve surgery.

To learn more about this clinical trial, please email: Claudia Merlin (Claudia.Merlin@mountsinai.org)