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

NCT07037446 | Enrolling By Invitation DMC

• 1 other identifier: Occ2023_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Paravalvular Leak Device (PLD)

Keywords

PLD Registry

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects (SADEs) including, but not limited to major cardiac arrhythmia (ventricular tachycardia/VF), procedure-related death, procedure-related stroke, rehospitalizations, systemic embolism, severe hemolysis, device embolization, infective endocarditis, prosthetic impingement, valvular regurgitation or vascular complications requiring surgery up to 1-year post-implantation, during the procedure new or worsening prothesis dysfunction, coronary obstruction, transfusion requirement, conversion to open surgery or unplanned intervention.

  1 year

Secondary Outcomes (1)

• Secondary endpoint

  3 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. The investigation population matches the target population.

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

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (9)

İzmir Bayraklı Şehir Hastanesi

Izmir, Bayraklı, 35540, Turkey (Türkiye)

Location

Gülhane Eğitim Araştırma Hastanesi

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location

Mehmet Akif Ersoy GKDC Eğitim Araştırma Hastanesi

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Tekirdağ Namık Kemal Üniversitesi Hastanesi

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

SBÜ Etlik Şehir Hastanesi Göğüs Kalp ve Damar Hastalıkları

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Yıldırım, 16310, Turkey (Türkiye)

Location

Hacettepe Üniversitesi

Ankara, Turkey (Türkiye)

Location

Kocaeli Üniversitesi Hastanesi

Kocaeli, Turkey (Türkiye)

Location

Özel Ankara Güven Hastanesi

Ankara, Çankaya, 06540, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 3, 2025

Record last verified: 2025-06

Locations

TU (9)