CE Mark Study for the Harpoon Medical Device

Not Applicable

Completed

Conditions: Mitral Valve Prolapse
Mitral Valve Insufficiency
Mitral Valve Regurgitation

Brief 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Harpoon Medical Device	Harpoon Artificial ePTFE Chords	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.

Primary Outcome Measures

Name	Time	Method
Subject's Procedural Success During the First 30 Days	End of procedure through 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.
Subject's Serious Adverse Events (SAE) Through Discharge	Discharge, an average of 5 days post implant	Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days	Procedure and 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months	Subject's freedom from Serious Adverse Events at \>30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Severity of Mitral Regurgitation Over Time	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months	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.

Locations (4): Ospedale San Raffaele Hospital
🇮🇹
Milan, Italy
University Hospital Padova
🇮🇹
Padova, Italy
University Hospital Southampton NHS Trust
🇬🇧
Southampton, United Kingdom
The Royal Brompton and Harefield NHS Foundation Trust
🇬🇧
London, United Kingdom