Beating Heart Mitral Valve Repair With the HARPOON™ System

RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).

Inclusion criteria

Each subject is required to meet all of the following inclusion criteria:

• Patient is >/= 21 years old.
• Presence of severe degenerative mitral regurgitation with mid-segment posterior leaflet prolapse (without commissural involvement) by echocardiographic study.
• Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.
• Patient competent to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation.

Exclusion criteria

Patients will be excluded if ANY of the following criteria apply:

• Functional mitral regurgitation (FMR).
• Evidence of anterior or bileaflet prolapse.
• Severe mitral annular calcification (MAC).
• Moderate or greater leaflet calcification.
• Fragile or thinning apex (e.g. LV aneurysm).
• Have undergone cardiac or peripheral vascular procedures within 30 days prior to the trial procedure.
• Planned cardiac or peripheral vascular procedures within 30 days after the trial procedure.
• Requirement for concomitant cardiac surgery.
• Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg).
• Severe aortic stenosis or insufficiency.
• Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid regurgitation are not excluded.)
• Left ventricular ejection fraction (LVEF) <30%, or severely impaired right ventricular dysfunction as measured by the core lab.
• Any history of endocarditis.
• Contraindication to cardiac surgery, including hostile chest or history of mediastinal radiation.
• Previous structural heart intervention (e.g. any heart valve replacement or repair procedures). Previous percutaneous coronary intervention (PCI) is allowed.
• Previous coronary artery bypass grafting (CABG).
• Stroke within 30 days prior to index procedure.
• ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure.
• Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or MELD score of ≥ 13]).
• Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2).
• Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices).
• History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL).
• Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments (as assessed by Case Review Committee).
• Refuse blood products.
• Planned treatment with any other investigational device or procedure through 1-year follow-up, or who are currently participating in an investigational drug or device trial.
• Carotid stenosis ≥ to 80% at time of enrollment.
• Rheumatic heart disease including rheumatic mitral stenosis.
• Pregnant or lactating at the time of enrollment (women of childbearing age should have negative pregnancy test within 72 hours of surgery) or planning pregnancy within the next 12 months.
• Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator.
• Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
• Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum).
• Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation).
• Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen.

Intra-operative exclusion criteria

• No longer meets eligibility criteria based on intra-operative assessment.