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: 6 countries
• Sites: 22

Brief Summary

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.

Conditions

Paravalvular Leak

Keywords

PLD Registry; Paravalvular leak (PVL); Transcatheter paravalvular leak closure; Occlutech PLD; PLD; Prosthetic heart valve; Mitral PVL; Aortic PVL

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  Primary endpoint The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects, 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 The primary efficacy endpoint is defined as successful implantation of the PLD device with the recommended accessories and delivery system with effective closure of the paravalvular leak (defined as reduction in paravalvular regurgitation of ≥1 grade leak36 , presence of a residual PVL greater than mild as assessed by echocardiography post implantation FUP,

  1 year

Secondary Outcomes (1)

• Secondary endpoint

  3 year

Interventions

Transcatheter paravalvular leak closure device 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 appropriate access route (eg, transseptal/retrograde/transapical) based on patient anatomy and operator assessment.

Also known as: Occlutech Paravalvular Leak Device, Occlutech PLD

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 (22)

Medical University of Silesia

Katowice, France

Location

À l'Infirmerie Protestante de Lyon

Lyon, France

Location

Hôpital Européen

Marseille, France

Location

Hôpital Marie Lannelongue (Paris)

Paris, France

Location

Deutsches Herzzentrum der Charité in Berlin

Berlin, Germany

Location

University Hospital Dresden

Dresden, Germany

Location

University Hospital Munich

München, Germany

Location

Hippokration Hospital

Athens, Greece

Location

Sotiria Hospital

Athens, Greece

Location

Interbalkan European Medical Center, Heart Center Thessaloniki

Thessaloniki, Greece

Location

Gottsegen National Cardiovascular Center

Budapest, Hungary

Location

Medical School of the University

Szeged, Hungary

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

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

MeSH Terms

Conditions

Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• 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: July 31, 2026

Record last verified: 2026-07

Locations

DE (3); ES (1); GR (3); FR (4); HU (2); TU (9)