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

N/AEnrolling By InvitationNCT07037446

Occlutech International AB200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Paravalvular Leak

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Medical University of Silesia

Katowice, France

À l'Infirmerie Protestante de Lyon

Lyon, France

Hôpital Européen

Marseille, France

Hôpital Marie Lannelongue (Paris)

Paris, France

Deutsches Herzzentrum der Charité in Berlin

Berlin, Germany

University Hospital Dresden

Dresden, Germany

University Hospital Munich

München, Germany

Hippokration Hospital

Athens, Greece

Sotiria Hospital

Athens, Greece

Interbalkan European Medical Center, Heart Center Thessaloniki

Thessaloniki, Greece

...and 12 more locations

Outcomes

Primary Outcomes

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,

Time frame: 1 year

Secondary Outcomes

Secondary endpoint

Secondary 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, acute kidney injury, systemic embolism, severe hemolysis, device embolization, infective endocarditis, prosthetic impingement, valvular regurgitation or bleeding/major vascular or cardiac structural complications requiring surgery from 1 year to 3-year post-implantation. This will also assess all minor complications such as transient hemolysis, vascular complications not requiring surgery, or all minor complications which are deemed relevant at the discretion of each investigator. Additionally, an assessment of all Serious Adverse Events (SAE) will be included in the analyses.

Time frame: 3 year