CE Mark Study for the Harpoon Medical Device

Mitral Valve Insufficiency Clinical Trial

— TRACER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768870
• Other study ID #: HMCE-1002-00k
• Status: Completed
• Phase: N/A
• Start date: April 28, 2016
• Est. completion date: September 6, 2022

Study information

• Verified date: January 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 6, 2022
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Mitral Valve Regurgitation
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele Hospital	Milan
Italy	University Hospital Padova	Padova
United Kingdom	The Royal Brompton and Harefield NHS Foundation Trust	London
United Kingdom	University Hospital Southampton NHS Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Italy,  United Kingdom, 

References & Publications (1)

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, Ko — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End of procedure through 30 days
Primary	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
Primary	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
Secondary	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
Secondary	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