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A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
Condition: Paravalvular Leak · Sponsor: Occlutech International AB
About this study
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically significant mitral or aortic paravalvular leaks after previously implanted prosthetic heart valves who undergo transcatheter PVL closure in routine clinical practice. Up to 200 subjects are planned to be enrolled and followed after the procedure (Day 1-7, Day 30, 6-12 months, and annually up to 3 years) to evaluate device safety (including serious adverse device effects) and effectiveness, including reduction of paravalvular regurgitation assessed by echocardiography and clinical outcomes such as improvement in heart failure symptoms and/or reduced need for hemolysis-related transfusions.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (22)
| Medical University of Silesia | Katowice, France | — |
| À l'Infirmerie Protestante de Lyon | Lyon, France | — |
| Hôpital Européen | Marseille, France | — |
| Hôpital Marie Lannelongue (Paris) | Paris, France | — |
| Deutsches Herzzentrum der Charité in Berlin | Berlin, Germany | — |
| University Hospital Dresden | Dresden, Germany | — |
| University Hospital Munich | München, Germany | — |
| Hippokration Hospital | Athens, Greece | — |
| Sotiria Hospital | Athens, Greece | — |
| Interbalkan European Medical Center, Heart Center Thessaloniki | Thessaloniki, Greece | — |
| Gottsegen National Cardiovascular Center | Budapest, Hungary | — |
| Medical School of the University | Szeged, Hungary | — |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07037446