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
Enrolling by invitation
Conditions studied: Paravalvular Leak
In brief
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.
Key facts
- Study ID
- NCT07037446
- Run by
- Occlutech International AB
- People needed
- 200
- Starts
- 2025-02-05
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient meeting the indication and area of application of the PLD device as laid down in the IFU.
- The Occlutech® PLD is indicated for patients with a significant leak that causes hemodynamically significant heart failure or hemolysis which requires recurrent blood transfusions. It is further indicated for patients who are deemed at high risk for surgery after consultation with the surgeon or as an alternative to surgery with less operational time and recovery period.
- Male of female patients
- Patients of age ≥ 18 years
- Patients understanding the nature of the study and providing their informed consent to participation.
- Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
You may not qualify if…
- Contraindications as described in the IFU:
- Acute infection or any serious infection 1 month prior to procedure
- Adequate oral anti-coagulation therapy / platelet inhibition is not possible post-intervention.
- Allergies to nickel and/or titanium and/or nickel/titanium-based materials
- Intolerance to contrast agents
- Known coagulation disorder
- Known intra-cardiac thrombus
- Recent pelvic venous thrombosis
- Recent myocardial infarction or a surgical bypass operation in the last 30 days Note: a positive result to a pregnancy test necessitates the exclusion of the subject from the registry.
Where it is running
- 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
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
- İzmir Bayraklı Şehir Hastanesi — Izmir, Bayraklı, Turkey (Türkiye)
- Gülhane Eğitim Araştırma Hastanesi — Ankara, Keçiören, Turkey (Türkiye)
- Mehmet Akif Ersoy GKDC Eğitim Araştırma Hastanesi — Istanbul, Küçükçekmece, Turkey (Türkiye)
- Tekirdağ Namık Kemal Üniversitesi Hastanesi — Tekirdağ, Süleymanpaşa, Turkey (Türkiye)
- SBÜ Etlik Şehir Hastanesi Göğüs Kalp ve Damar Hastalıkları — Ankara, Yenimahalle, Turkey (Türkiye)
- SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi — Bursa, Yıldırım, Turkey (Türkiye)
- Hacettepe Üniversitesi — Ankara, Turkey (Türkiye)
- Kocaeli Üniversitesi Hastanesi — Kocaeli, Turkey (Türkiye)
- Özel Ankara Güven Hastanesi — Ankara, Çankaya, Turkey (Türkiye)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.