CE Mark Study for the Harpoon Medical Device (TRACER)

Edwards Lifesciences

Status: Completed

Conditions: Mitral Valve Regurgitation; Mitral Valve Insufficiency; Mitral Valve Prolapse

Treatments: Device: Harpoon Artificial ePTFE Chords

Study type: Interventional

Funder types: Industry

Identifiers

NCT02768870

HMCE-1002-00k

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Harpoon Medical Device

Experimental group

Description:

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.

Treatment:

Device: Harpoon Artificial ePTFE Chords