Overview

This trial is active, not recruiting.

Conditions mitral valve regurgitation, mitral valve prolapse, mitral valve insufficiency
Treatment mitral valve repair
Sponsor Harpoon Medical
Start date February 2015
End date February 2017
Trial size 13 participants
Trial identifier NCT02432196, HMFIM -1000-PL

Summary

This is a Prospective, Single Arm, Single Group Assignment, EU study to demonstrate the feasibility and safety of the Harpoon Medical TSD-5 in subjects with degenerative MR

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implanting ePTFE sutures as artificial chordae tendineae using the TSD-5
mitral valve repair
Harpoon Medical TSD-5

Primary Outcomes

Measure
Procedural Success
time frame: 30 days

Secondary Outcomes

Measure
Procedural Safety
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Age > 18 years - All subjects referred for mitral valve surgery - Presence of moderate to severe or severe mitral regurgitation as read on an echocardiographic study performed within 6 months prior to procedure. - Able to sign informed consent - Presence of isolated posterior leaflet mitral valve prolapse - Subject is willing to return for follow-up and is capable of participating in all testing associated with this clinical investigation Exclusion Criteria: - < 18 years of age - Infective endocarditis - Severe Tricuspid regurgitation - Anterior or bileaflet prolapse - Functional mitral regurgitation - Radiation or inflammatory (rheumatic) valve disease - Requirement for concomitant cardiac surgery (e.g. coronary artery bypass grafting (CABG), aortic valve surgery, etc.) - Cardiogenic shock at the time of enrollment - ST segment elevation myocardial infarction requiring intervention within 7 days prior to enrollment - Evidence of cirrhosis or hepatic synthetic failure - Pregnancy at the time of enrollment - Severe pulmonary hypertension (PA systolic pressure > 60 mmHg) - Previous cardiac surgery, or surgery on the left thoracic cavity or the cardiac apex - Left ventricular, atrial or appendage thrombus - Severely calcified mitral annulus - Recent stroke (in the prior six months) - STS risk score (for mitral valve repair) > 6 percent - Subjects with contraindications to transesophageal echocardiography - Severe left ventricular dysfunction (EF < 40 %) - Excessively thin mitral leaflets - Renal insufficiency (CKD stage 3 or above GFR < 60)

Additional Information

Official title First In Man - Clinical Validation of the TSD-5
Principal investigator Krzysztof Bartus, MD PhD
Description Pairs of ePTFE suture will be placed in the posterior leaflet of the mitral valve using the Harpoon Medical TSD-5 in order to establish effective coaptation of the mitral leaflets
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Harpoon Medical.