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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.
Jagiellonian University
Krakow, Poland
Instytut of Kardiologii & Transplantology
Warsaw, Poland
Number of Subjects With Procedural Success During the First 30 Days
To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.
Time frame: Procedure, discharge, and 30 days
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
Time frame: Procedure, Discharge and 30 Days
Subject's Severity of Mitral Regurgitation Over Time
Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time frame: 6 Months, 12 Months, and 24 Months
Subject's Freedom From Serious Adverse Events Over Time
Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time frame: 6 Months, 12 Months, and 24 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.