The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant 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 chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.
John Paul II University Hospital
Krakow, Poland
Instytut of Kardiologii & Transplantology
Warsaw, Poland
Subject's Procedural Success During the First 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.
Time frame: Procedure through 30 days
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 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.
Time frame: Procedure through 30 days
Subject's Serious Adverse Events (SAE) Through Discharge
Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.
Time frame: Discharge, an average of 6 days post implant
Subject's Severity of Mitral Regurgitation Over Time
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.
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Subject's freedom from Serious Adverse Events at \>30 days post-implant. Time to events were estimated by Kaplan-Meier method.
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Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months