Open Actively Recruiting

Beating Heart Mitral Valve Repair With the HARPOON™ System

About

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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
21 Years
Maximum Age
N/A

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 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.
  • 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.

Join this Trial

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Study Stats
Protocol No.
20-001112
Category
Surgery
Contact
NANCY SATOU
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04375332
For detailed technical eligibility, visit ClinicalTrials.gov.