Beating Heart Mitral Valve Repair With the HARPOON™ System

Running, not enrolling · Not applicable

Conditions studied: Mitral Regurgitation

In brief

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).

Key facts

Study ID: NCT04375332
Run by: Edwards Lifesciences
People needed: 25
Starts: 2020-12-16
Expected to finish: 2027-12-20
Last updated by the study team: 2025-08-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

UCSF — San Francisco, California, United States
Piedmont Heart Institute — Atlanta, Georgia, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Johns Hopkins — Baltimore, Maryland, United States
University of Michigan Health System — Ann Arbor, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
OHSU Knight Cardiovascular Institute — Portland, Oregon, United States
Centennial Medical Center — Nashville, Tennessee, United States
Intermountain Heart Institute — Murray, Utah, United States

Full record on ClinicalTrials.gov

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