CE Mark Study for the Harpoon Medical Device (TRACER)

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Insufficiency; Mitral Valve Prolapse; Mitral Valve Regurgitation
• Intervention / Treatment: Device: Harpoon Artificial ePTFE Chords

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Ospedale San Raffaele Hospital
  • Padova, Italy, 351278
    • University Hospital Padova
• United Kingdom
  • London, United Kingdom, SH3 6NP
    • The Royal Brompton and Harefield NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Evidence of cirrhosis or hepatic synthetic failure
• Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
• Severe pulmonary hypertension (PA systolic pressure > 70 mmHg)
• Previous cardiac surgery, or surgery on the left pleural space
• Left ventricular, atrial or appendage thrombus
• Severely calcified mitral leaflets
• Recent stroke (< 6 months) with permanent impairment
• EuroScore (for mitral valve repair) > 8%
• Patients with contraindications to Transoesophageal echocardiography
• Severe left or right ventricular dysfunction
• NYHA Class IV
• Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2)
• Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
• Patient with non-cardiac co-morbidities and life expectancy < 1 year
• Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Harpoon Medical Device; This is a prospective, single arm, nonrandomised, multi-center EU study to demonstrate the performance and safety of the Harpoon Medical device in patients with degenerative MR.	Device: Harpoon Artificial ePTFE Chords; It is anticipated that use of the Harpoon device could achieve similar outcomes to open cardiac surgery while decreasing the invasiveness of mitral valve repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days	Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.	Procedure and 30 days
Subject's Serious Adverse Events (SAE) Through Discharge	Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.	Discharge, an average of 5 days post implant
Subject's Procedural Success During the First 30 Days	Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to </=moderate at the conclusion of the procedure and at 30 days post-procedure.	End of procedure through 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Severity of Mitral Regurgitation Over Time	Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Gino Gerosa, MD, University Hospital Padova; Principal Investigator: Ottavio Alfieri, MD, OSR San Raffaele Hospital; Principal Investigator: Alison Duncan, MD, The Royal Brompton Hospital

Publications and helpful links

General Publications

• Gammie JS, Bartus K, Gackowski A, D'Ambra MN, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Moat N, Duncan A, Yadev R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pitterello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P. Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial. J Am Coll Cardiol. 2018 Jan 2;71(1):25-36. doi: 10.1016/j.jacc.2017.10.062. Epub 2017 Nov 1.
• Gammie JS, Bartus K, Gackowski A, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Duncan A, Yadav R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pittarello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P, D'Ambra MN. Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes. Eur J Cardiothorac Surg. 2021 Jan 4;59(1):199-206. doi: 10.1093/ejcts/ezaa256.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2016
• Primary Completion (Actual): November 6, 2017
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimated): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Transapical; Mitral Valve Repair; Artificial Chordae
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Mitral Valve Insufficiency; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: HMCE-1002-00k

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes