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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter paravalvular leak closure device.
- Who it may be relevant to
- Registry conditions: Paravalvular Leak. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Greece, Hungary, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
International, multicenter, observational post-marketing follow-up registry evaluating real-world use of transcatheter paravalvular leak (PVL) closure with the Occlutech Paravalvular Leak Device (PLD) in adult patients with clinically significant mitral or aortic PVL after prior prosthetic heart valve implantation. The registry includes retrospective and prospective data collection across participating sites and follows patients for up to 3 years to characterize longer-term safety and clinical performance of PVL closure with the device in routine clinical practice.
Interventions
- Device Transcatheter paravalvular leak closure device
Transcatheter closure of clinically significant mitral or aortic paravalvular leak (PVL) using the Occlutech Paravalvular Leak Device (PLD) in routine clinical practice. The PLD is an implantable occluder delivered percutaneously via catheter with the manufacturer-recommended delivery system and accessories, and deployed across the PVL under fluoroscopic and echocardiographic guidance (eg, TEE/3D TEE), according to the IFU and local standard of care. The procedure may be performed via an appropr
Primary outcome measures
- Primary endpoint [Time frame: 1 year]
Secondary outcome measures (1)
- Secondary endpoint [Time frame: 3 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Turkey (Türkiye) · 9 centers
- İzmir Bayraklı Şehir Hastanesi — Izmir
- Gülhane Eğitim Araştırma Hastanesi — Ankara
- Mehmet Akif Ersoy GKDC Eğitim Araştırma Hastanesi — Istanbul
- Tekirdağ Namık Kemal Üniversitesi Hastanesi — Tekirdağ
- SBÜ Etlik Şehir Hastanesi Göğüs Kalp ve Damar Hastalıkları — Ankara
- SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi — Bursa
- Hacettepe Üniversitesi — Ankara
- Kocaeli Üniversitesi Hastanesi — Kocaeli
- … and 1 more center
France · 4 centers
- Medical University of Silesia — Katowice
- À l'Infirmerie Protestante de Lyon — Lyon
- Hôpital Européen — Marseille
- Hôpital Marie Lannelongue (Paris) — Paris
Germany · 3 centers
- Deutsches Herzzentrum der Charité in Berlin — Berlin
- University Hospital Dresden — Dresden
- University Hospital Munich — München
Greece · 3 centers
- Hippokration Hospital — Athens
- Sotiria Hospital — Athens
- Interbalkan European Medical Center, Heart Center Thessaloniki — Thessaloniki
Hungary · 2 centers
- Gottsegen National Cardiovascular Center — Budapest
- Medical School of the University — Szeged
Spain · 1 center
- Hospital de la Santa Creu i Sant Pau — Barcelona
Identifiers
NCT: NCT07037446 · Occ2023_01