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CE Mark Study for the Harpoon Medical Device | Clinical Trials | Clareo Health

COMPLETEDNA

CE Mark Study for the Harpoon Medical Device

Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial

NCT02768870•Edwards Lifesciences

Summary

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Detailed Description

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years
•Patient referred for mitral valve surgery
•Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure
•Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
•Degenerative mitral valve disease
•Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
•Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria

•Age \< 18 years
•Infective endocarditis
•Anterior or bileaflet prolapse
•Functional MR
•History of Mediastinal Radiation
•Inflammatory (rheumatic) valve disease
•Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
•Symptomatic coronary artery disease
•Cardiogenic shock at the time of enrollment
•ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
+15 more criteria

Locations (4)

Ospedale San Raffaele Hospital

Milan, Italy

University Hospital Padova

Padua, Italy

The Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom

University Hospital Southampton NHS Trust

Southampton, United Kingdom

Key Dates

Start Date

April 28, 2016

Primary Completion Date

November 6, 2017

Completion Date

September 6, 2022

Last Updated

January 11, 2024

Enrollment

ACTUAL participants

Conditions

Mitral Valve RegurgitationMitral Valve ProlapseMitral Valve Insufficiency

Interventions

Harpoon Artificial ePTFE Chords

DEVICE

AI-Based Shape and Function Analysis of Mitral Valve Prolapse Using 3D Ultrasound

NCT07384871

Mitral Valve ProlapseMyxomatous Mitral Valve Degeneration

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RECRUITINGNA

Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

NCT06378996

Mitral Valve ProlapseVentricular Arrythmia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CE Mark Study for the Harpoon Medical Device

Inclusion Criteria

Exclusion Criteria

AI-Based Shape and Function Analysis of Mitral Valve Prolapse Using 3D Ultrasound

Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

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