Status:
TERMINATED
Observational Registry on the HARPOON Device
Lead Sponsor:
Edwards Lifesciences
Collaborating Sponsors:
ICON plc
Conditions:
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
Detailed Description
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.
Eligibility Criteria
Inclusion
- Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.
Exclusion
- N/A
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04393779
Start Date
October 2 2020
End Date
November 17 2022
Last Update
January 29 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, Germany, 89070
2
Rhön Klinikum Kardiochirurgie
Bad Neustadt an der Saale, Bavaria, Germany, 97616
3
Klinikum Passau
Passau, Bavaria, Germany, 94032
4
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany, 37075