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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Primary endpoint [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Secondary endpoint [Срок оценки: 3 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Turkey (Türkiye) · 9 центров

• 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
• … и ещё 1 центр

Франция · 4 центра

• Medical University of Silesia — Katowice
• À l'Infirmerie Protestante de Lyon — Lyon
• Hôpital Européen — Marseille
• Hôpital Marie Lannelongue (Paris) — Paris

Германия · 3 центра

• Deutsches Herzzentrum der Charité in Berlin — Berlin
• University Hospital Dresden — Dresden
• University Hospital Munich — München

Греция · 3 центра

• Hippokration Hospital — Athens
• Sotiria Hospital — Athens
• Interbalkan European Medical Center, Heart Center Thessaloniki — Thessaloniki

Венгрия · 2 центра

• Gottsegen National Cardiovascular Center — Budapest
• Medical School of the University — Szeged

Испания · 1 центр

• Hospital de la Santa Creu i Sant Pau — Barcelona

Идентификаторы

NCT: NCT07037446 · Occ2023_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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