An observational study in Paravalvular Leak, sponsored by Occlutech International AB. Enrolling by invitation at 22 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Occlutech International AB · Observational
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.
40 studies on the registry are indexed under Leukomalacia, Periventricular; 5 are open to participants now.
This study's planned enrollment of 200 is above the median of 66 across 10 observational studies indexed under Leukomalacia, Periventricular.
Browse Leukomalacia, Periventricular studies →Occlutech International AB is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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. The investigation population matches the target population.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Occlutech Paravalvular Leak Device, Occlutech PLD
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 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
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Leukomalacia, Periventricular →
Occlutech International AB