Paravalvular LeakPLD REGISTRYNCT07037446
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
An observational study of Paravalvular Leak, run by Occlutech International AB at 22 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paravalvular Leak
- What is being tested?
- Transcatheter paravalvular leak closure device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 5 Feb 2025to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 6 countries
Turkey (Türkiye)9 sites
Gülhane Eğitim Araştırma Hastanesi
Ankara, Keçiören, 06010
SBÜ Etlik Şehir Hastanesi Göğüs Kalp ve Damar Hastalıkları
Ankara, Yenimahalle, 06170
Hacettepe Üniversitesi
Ankara
Özel Ankara Güven Hastanesi
Ankara, Çankaya, 06540
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Yıldırım, 16310
Mehmet Akif Ersoy GKDC Eğitim Araştırma Hastanesi
Istanbul, Küçükçekmece, 34303
İzmir Bayraklı Şehir Hastanesi
Izmir, Bayraklı, 35540
Kocaeli Üniversitesi Hastanesi
Kocaeli
Tekirdağ Namık Kemal Üniversitesi Hastanesi
Tekirdağ, Süleymanpaşa, 59100
France4 sites
Medical University of Silesia
Katowice
À l'Infirmerie Protestante de Lyon
Lyon
Hôpital Européen
Marseille
Hôpital Marie Lannelongue (Paris)
Paris
Germany3 sites
Deutsches Herzzentrum der Charité in Berlin
Berlin
University Hospital Dresden
Dresden
University Hospital Munich
München
Greece3 sites
Hippokration Hospital
Athens
Sotiria Hospital
Athens
Interbalkan European Medical Center, Heart Center Thessaloniki
Thessaloniki
Hungary2 sites
Gottsegen National Cardiovascular Center
Budapest
Medical School of the University
Szeged
About this study
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.
Read the detailed description
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.
- Conditions
- Paravalvular Leak
- Being tested
- Transcatheter paravalvular leak closure device
- Keywords
- PLD Registry, Paravalvular leak (PVL), Transcatheter paravalvular leak closure, Occlutech PLD, PLD, Prosthetic heart valve, Mitral PVL, Aortic PVL
- Medical subject headings
- Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter paravalvular leak closure deviceDevice
Also called Occlutech Paravalvular Leak Device, Occlutech PLD
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start5 Feb 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paravalvular LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037446
- Sponsor's protocol ID
- Occ2023_01
- Acronym
- PLD REGISTRY
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07037446
- Acronym / sponsor ID
- PLD REGISTRY / Occ2023_01
- Conditions
- Paravalvular Leak
- Keywords
- PLD Registry, Paravalvular leak (PVL), Transcatheter paravalvular leak closure, Occlutech PLD, PLD, Prosthetic heart valve, Mitral PVL, Aortic PVL
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter paravalvular leak closure deviceAlso: Occlutech Paravalvular Leak Device, Occlutech PLDTranscatheter 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. | Device | – |
Primary outcome
Primary endpoint
Time frame: 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,
1 secondary outcome
Secondary endpoint
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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PARADIGM: Amplatzer Valvular Plug for PVL Closure
Paravalvular Aortic Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paravalvular Leak, run by Occlutech International AB at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Turkey (Türkiye), France, Germany, Greece, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.