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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

Sponsor: Occlutech International AB

Summary

Synopsis Title of the study 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 Study Number Occ2023\_01 Sponsor Occlutech International AB Landskronavägen 2 SE-252 32 Helsingborg Sweden Represented by Clinical Research Manager Gönül Sönmez Utkun Occlutech Tıbbi Urunler San.ve Tic.Ltd.Sti. Yeşilköy SB Mah. E Blok Sok, Occlutech Apt. No:6 34149, Istanbul, Turkey Coordinating Investigator Prof. Dr. Eustaquio Onorato, MD, FSCAI, FESC Unità Operativa di Cardiologia Universitaria Ospedale Galeazzi-Sant'Ambrogio, GSD, IRCCS Via Cristina Belgioioso, 173 20157 Milano, Italy Name of Investigational Device Occlutech® Paravalvular Leak Device (PLD) Indication The Occlutech PLD is a medical device intended to close a paravalvular leak (PVL). This leak is a relevant post-operational complication after the bioprosthetic or mechanical heart valve replacement or a result of paravalvular tissue rupture (early or late occurrence) or endocarditis, with possible lowintensity of heart murmurs. The PVL closure with 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. Study purpose The objective of the study is to evaluate the safety and efficacy of the Occlutech PLD in patients requiring transcatheter closure of paravalvular leaks after previously implanted prosthetic heart valves. Study design This is an international, multicenter, retrospective and prospective, post marketing follow-up registry to monitor the efficacy and safety of the Occlutech® Paravalvular Leak Device (PLD) in subjects with mitral or aortic paravalvular leaks. * Efficacy and safety of implanted device(s) will be assessed on Day 1 to 7, Day 30 (±15 days), 6 months to 1 year (±3 months), 1 year to 2 years (±3 months), 2 years to 3 years (±3 months) after the procedure. * Patients will be treated according to the instruction-for-use of the device and according to clinical routine * Procedures will be performed at sites having appropriate laboratory support and adequately trained interventional and imaging personnel. Procedure will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transseptal puncture, anterograde, retrograde or transapical device delivery approaches to PVL interventions. Sample size consideration It is planned to enroll up to 200 subjects in which 150 subjects will be considered as evaluable subjects (i.e. followed-up for ≥1y) is a pragmatic approach for such a study, based on the recent publication of Onorato et al1. and 50 subjects are considered as drop-out (calculated as of 25% for the study). This guarantees 95%-CIs for continuous variables with a range of mean +/-0.16 standard deviations (SD), and binary variables (incidence or success rates r) with a range of r +/-0.16 (r(1 - r))½. This precision is sufficient for the descriptive study objective. Subject population Planned subject population: 200 subjects requiring transcatheter closure of paravalvular leaks after previously implanted prosthetic heart valves. Subjects will be screened to determine eligibility for this registry based on inclusion and exclusion criteria, medical history, demographic data, vital signs and clinical laboratory tests, ECG records and appropriate echocardiography. Study objectives * To evaluate the safety of the Occlutech PLD by using its accessory and delivery system in patients requiring transcatheter closure of paravalvular leaks. * To evaluate the efficacy of the Occlutech PLD by using its accessory and delivery system in patients requiring transcatheter closure of paravalvular leaks. Additional exploratory objectives To evaluate the compatibility and usability of the Occlutech PLD with the Occlutech Pistol Pusher (OPP) and the Occlutech Delivery Set III (ODS III) through a practitioner's questionnaire if applicable.

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