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

Inclusion and Exclusion Criteria Inclusion Criteria

• Patient meeting the indication and area of application of the PLD device as described 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 or as an alternative to surgery after heart team evaluation including the surgeon.

* Male of female patients
* Patients of age ≥ 18 years
* Patients understanding the nature of the stu...

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.