Perimembranous Ventricular Septal DefectNCT04034498
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
An observational study of Perimembranous Ventricular Septal Defect, run by Occlutech International AB at 8 sites in 4 countries.
Trial summary
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perimembranous Ventricular Septal Defect
- How many people
- 50 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 7 Jul 2019to Jul 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician
Who may be able to join
- Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
Who cannot join
- Occlutech® PmVSD Occluder is contraindicated for the following:
- Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
- Patients less than 10.0 kg
- Patients with sepsis (local or generalized)
- Patients with left ventricle to right atrial shunting
- Patients with right to left shunting through the defect
Show all 17Show fewer
- Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device
- Patients with complex heart lesions such as tetralogy of fallot
- History of repeated pulmonary infection
- Any type of serious infection 1 month prior to procedure
- Malignancy where life expectancy is less than 3 years
- Demonstrated intracardiac thrombi on echocardiography
- Patients with allergy to anti-platelet or anticoagulant therapy
- Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials
- Patients with intolerance to contrast agents
- Patients with active bacterial infections
- Patients with very small vessels which are not suitable for recommended delivery sheath sizes
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Turkey (Türkiye)4 sites
Osmangazi University Faculty of Medicine Hospital
Eskişehir, 26040
Gaziantep University Hospital
Gaziantep
Izmir University of Health Sciences Tepecik Training and Research Hospital
Izmir, 35020
Kocaeli University Research and Application Hospital
Kocaeli, 41001
Thailand2 sites
Queen Sirikit National Institute of Child Health
Bangkok
Prince of Songkla University
Hat Yai
About this study
Official title: A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
- Conditions
- Perimembranous Ventricular Septal Defect
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).
Measured: 1 year following implantation
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.
Measured: 1 year following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start7 Jul 2019
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimembranous Ventricular Septal DefectStudies 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
- Other
- Enrolment
- 50 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
- NCT04034498
- Sponsor's protocol ID
- Occ2018-01
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects
- ClinicalTrials.gov ID
- NCT04034498
- Acronym / sponsor ID
- Occ2018-01
- Conditions
- Perimembranous Ventricular Septal Defect
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Jul 2019 (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.
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician
Key inclusion criteria (1 listed)
- Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
Key exclusion criteria (17 listed)
- Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
- Patients less than 10.0 kg
- Patients with sepsis (local or generalized)
- Patients with left ventricle to right atrial shunting
- Patients with right to left shunting through the defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
Time frame: 1 year following implantation
The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
Time frame: 1 year following implantation
The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.
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 16 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimembranous Ventricular Septal Defect, run by Occlutech International AB at 8 sites in 4 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 1 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye), Thailand, Ireland, Vietnam. 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?
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects. (time frame: 1 year following implantation). The study lists 2 primary outcomes in all. 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 16 Jan 2026.