At a glance
ClinicalIndex Comparison Record- ✓Age 60 years or older
- ✓Severe (3+ or 4+/4+) primary degenerative mitral regurgitation
- ✓Clinical indication for mitral valve intervention verified by heart team
- ✓Anatomically suitable for both surgical repair and transcatheter edge-to-edge repair
- ✕Non-degenerative types of primary MR such as cleft leaflet
- ✕Secondary or functional mitral regurgitation
- ✕Hypertrophic obstructive cardiomyopathy
- ✕IVC filter or permanent pacing/ICD leads interfering with TEER
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
In Brief
A clinical study evaluating Mitral valve repair and Transcatheter edge-to-edge repair for Mitral Valve Regurgitation. Active but no longer recruiting, targeting 450 participants across 62 sites in 5 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients who are randomized to the surgical arm will undergo mitral surgery.
In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Interventions
Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.
Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.