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

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

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.

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.

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.