A Study to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair with the HARPOON™ System


About this study

The purpose of this study is to evaluate the safety and effectiveness of the HARPOON System in the treatment of patients with severe degenerative mitral regurgitation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Patients must meet all of the following criteria to be considered for inclusion in this clinical investigation:

  • 21 years of age or older.
  • Presence of severe degenerative mitral regurgitation with isolated mid-segment posterior leaflet prolapse 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.
  • 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 or right ventricular ejection fraction (LVEF or RVEF) < 30% 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) with the exceptions of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
  • 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 m^2).
  • 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).
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arman Arghami, M.D., M.P.H.

Closed for enrollment

Contact information:

Jolene Erola M.B.A.

(507) 266-9515


More information


Publications are currently not available

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