Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Edwards Lifesciences
- Enrollment
- 26
- Locations
- 4
- Primary Endpoint
- Subject's Procedural Success During the First 30 Days
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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 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
Outcomes
Primary Outcomes
Subject's Procedural Success During the First 30 Days
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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 Severity of Mitral Regurgitation Over Time(6 months, 12 months, 18 months, 24 months, 30 months, and 36 months)