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Beating Heart Mitral Valve Repair With the HARPOON™ System

NCT04375332 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-26

No results posted yet for this study

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

Interventions

DEVICE

HARPOON™ Beating Heart Mitral Valve Repair System

Repair of the chordae tendinae in the mitral valve.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Vinod H. Thourani, MD · Dept of Cardiovascular Surgery, Piedmont Heart Institute

  • Konstantinos Koulogiannis, MD · Department of Cardiovascular Medicine Gagnon Cardiovascular Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2027-12-20
Completion
2027-12-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375332 on ClinicalTrials.gov