At a glance
ClinicalIndex Comparison Record- ✓Referred for mitral valve surgery with severe degenerative mitral regurgitation
- ✓Severe mitral regurgitation confirmed on echocardiography within 60 days before procedure
- ✓Age >18 years
- ✓Adequate coaptation surface judged suitable for ePTFE cordal implantation
- ✕Age <18 years
- ✕Anterior or bileaflet prolapse
- ✕Functional (not degenerative) mitral regurgitation
- ✕Infective endocarditis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - EFS/CE Mark Study for the Harpoon Medical Device in Poland
In Brief
A clinical study evaluating Harpoon Medical Device for Mitral Valve Regurgitation and 2 related conditions. Completed, enrolled 13 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.