Clinical trial NCT03285724: Safety and Performance Study of the Harpoon Mitral Valve Repair System
Official title: Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitral Valve Regurgitation
Mitral Valve Prolapse
Mitral Valve Insufficiency
Keywords: Mitral Valve Repair
Transapical
artificial chordae
bi-leaflet prolapse
anterior prolapse
posterior prolapse
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: The primary objective 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 TEE-guided ePTFE cordal 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 criteria: 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 cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
* Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse
* 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
* 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 Transesophageal 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

Primary outcomes:
measure: Number of Subjects With Procedural Success During the First 30 Days
timeFrame: Procedure, discharge, and 30 days
measure: Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
timeFrame: Procedure, Discharge and 30 Days
Secondary outcomes:
measure: Subject's Severity of Mitral Regurgitation Over Time
timeFrame: 6 Months, 12 Months, and 24 Months
measure: Subject's Freedom From Serious Adverse Events Over Time
timeFrame: 6 Months, 12 Months, and 24 Months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University
city: Warsaw
country: Poland
facility: Instytut of Kardiologii & Transplantology
Study officials:
affiliation: Jagiellonian University
name: Krzysztof Bartus, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: