Beating Heart Mitral Valve Repair With the HARPOON™ System

NCT04375332 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2019-05
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

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).

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Change in NYHA classification from Baseline to 5 years

  The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

  Baseline compared to 1 and 5 years

Study Arms (1)

HARPOON™ Beating Heart Mitral Valve Repair System

EXPERIMENTAL

Subjects who were treated with the HARPOON™ Beating Heart Mitral Valve Repair System

Device: HARPOON™ Beating Heart Mitral Valve Repair System

Interventions

HARPOON™ Beating Heart Mitral Valve Repair System DEVICE

Repair of the chordae tendinae in the mitral valve.

HARPOON™ Beating Heart Mitral Valve Repair System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (9)

UCSF

San Francisco, California, 94118, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

OHSU Knight Cardiovascular Institute

Portland, Oregon, 97239, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Intermountain Heart Institute

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Vinod H. Thourani, MD

  Dept of Cardiovascular Surgery, Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Konstantinos Koulogiannis, MD

  Department of Cardiovascular Medicine Gagnon Cardiovascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: December 16, 2020
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)