Status:
ACTIVE_NOT_RECRUITING
Beating Heart Mitral Valve Repair With the HARPOON™ System
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
Detailed Description
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 degenerat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04375332
Start Date
December 16 2020
End Date
December 20 2027
Last Update
August 26 2025
Active Locations (9)
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1
UCSF
San Francisco, California, United States, 94118
2
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
3
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
4
Johns Hopkins
Baltimore, Maryland, United States, 21231