Status:
TERMINATED
Safety and Performance Study of the Harpoon Mitral Valve Repair System
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Valve Regurgitation
Mitral Valve Prolapse
Eligibility:
All Genders
18+ years
Phase:
NA
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 sur...
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
- 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
- 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
Key Trial Info
Start Date :
May 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03285724
Start Date
May 16 2017
End Date
April 20 2018
Last Update
November 19 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jagiellonian University
Krakow, Poland
2
Instytut of Kardiologii & Transplantology
Warsaw, Poland, 04-628