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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter paravalvular leak closure 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Primary endpoint — 1 year
  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,

Trial sites (22)

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