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

Launched by OCCLUTECH INTERNATIONAL AB · Jun 17, 2025

Keywords

ClinConnect Summary

This is an international, real-world registry (an observational study) of the Occlutech Paravalvular Leak Device (PLD). It tracks how safe and effective the device is when used to close leaks around previously implanted heart valves in people with mitral or aortic paravalvular leaks. The study will enroll up to about 200 adults and follow them for up to 3 years after the procedure, collecting information during routine care rather than comparing to another treatment.

Who may be eligible? Adults aged 18 and older who have a significant paravalvular leak that is causing heart failure symptoms or hemolysis (blood problems) and who are considered high risk for surgery or for whom the device is an alternative to surgery after a heart-team evaluation. Key criteria include the ability to give informed consent and attend follow-up visits, with certain exclusions such as active infection, inability to use anticoagulants as needed, allergies to nickel/titanium or contrast agents, known clotting problems, recent major heart procedures, or pregnancy. Participants will have follow-up visits and imaging tests at several time points after implantation (from 1 week up to 3 years) to assess both safety (any serious device-related problems) and efficacy (whether the leak is reduced and whether transfusions for hemolysis decrease). There is an independent safety board overseeing the study, and the registry is not a randomized trial.

Gender

ALL

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.