Muscular Ventricular Septal DefectmVSD RegistryNCT05329350
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
An observational study of Muscular Ventricular Septal Defect, run by Occlutech International AB at 6 sites in 3 countries.
Trial summary
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects. The objectives of the study are: To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects. Read more about this study
- Who is it for?
- Ages 3 months to 80 years
- Conditions the study is for
- Muscular Ventricular Septal Defect
- What is being tested?
- Occlutech muscular ventricular septal defect (mVSD) Occluder
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 3 Mar 2022to 1 Jun 2031
- 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 3 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female patients of any age with a hemodynamically or clinically significant muscular ventricular septal defect (mVSD) who are candidates for non-surgical closure with the Occlutech mVSD Occluder in routine clinical practice (predominantly pediatric patients). Eligibility is confirmed based on protocol-defined inclusion/exclusion criteria and baseline clinical assessment, including medical history, demographics, vital signs, ECG and echocardiography; laboratory tests may be performed according to local standard of care.
Who may be able to join
- A participant will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
- Any age
- Male or female.
- Patients understand the nature of the study and provide their informed consent to participation.
- Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
- Contraindication
Show all 13Show fewer
- Hemodynamically relevant VSD shunt
- Congestive heart insufficiency
- Recurrent respiratory infections
- Failure to thrive.
- Significant left ventricle (LV) enlargement
- Significant left atrium (LA) enlargement
- Other clinical indication
Who cannot join
- The device is contraindicated for participants known to have any of the following:
- ⦁Active bacterial infections
- Active infection at the time of implantation
- Allergy to antiplatelet or anticoagulant therapy
- Allergy to nickel and/or titanium and/or nickel/titanium-based materials
- Any type of serious infection 1 month before the procedure
Show all 15Show fewer
- The aortic rim of less than 2 mm
- Demonstrated intracardiac thrombi on echocardiography
- Malignancy where life expectancy is less than 3 years
- mVSD diameter > 20 mm
- Perimembranous VSD
- Post-MI VSD
- Recent myocardial infarction or a surgical bypass operation in the last 30 days
- Sepsis (local or generalized)
- Septal thickness > 7 mm in the area of the Occluder placement
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Sur
Alper Akın, MD, +90 542 256 06 01, alperakin1@hotmail.com
Merve Demirtaş, SC, +90 549 6101287, merve.demirtas@medex-smo.com
- Not yet recruiting
Eskişehir Osmangazi Üniversite Hastanesi
Eskişehir, Odunpazarı, 26040
Birsen Uçar, MD, +90 506 397 85 85, drbucar@yahoo.com
Çiçek Kır, SC, +90 531 6974619, cicek.kir@medex-smo.com
- Recruiting
Gaziantep Unıversıty Hospital
Gaziantep, Şehitkamil, 27310
Osman Başpınar, MD, +90 532 345 54 77, osmanbaspinar@hotmail.com
- Not yet recruiting
İzmir Şehir Hastanesi
Izmir, Bayraklı, 35540
Nazmi Narin, MD, +90 533 770 64 94, nazmi.narin@gmail.com
Kumru Bademci, SC, +90 539 895 96 25, kumru.bademci@medex-smo.com
Ireland1 site, 1 recruiting
- Not yet recruiting
Children's Health Ireland
Dublin, N512
Damien Kenny, MD
Claire Josephine Karungi Betz, SC
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Royal Brompton Hospital
London, England, SW3 6NP
Prof Alain Fraisse, PI
About this study
Official title: A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
The objectives of the study are:
- To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
- To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
Read the detailed description
This is a multicenter, prospective, and retrospective, international, post-market clinical follow-up Study to monitor the efficacy and safety of the Occlutech mVSD in patients with muscular ventricular septal defects.
Safety and efficacy of implanted devices are assessed by echocardiography, vital signs, laboratory tests, and ECGs on Day 1 (within 48 hours post-procedure), follow-up 1 (between Day 30 and Day 60), follow-up 2 at 6 months (from Day 61 until 6 months), follow-up 3 at 1 year (from 6 months until 1 year), and follow-up 4 at 3 years (from 1 year until 3 years).
- Patients will be screened to determine eligibility for the registry based on inclusion/exclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.
- Participants are treated according to the instructions-for-use (IFU) of the device and according to clinical routine.
- Procedures are performed at sites having appropriate laboratory support and adequately trained imaging personnel. The procedure is performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transcatheter patent ductus arteriosus, atrial septal defect, and ventricular septal defect (VSD) closures.
Recruitment will be open until 50 Patients have been enrolled. The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.
The primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).
- Conditions
- Muscular Ventricular Septal Defect
- Being tested
- Occlutech muscular ventricular septal defect (mVSD) Occluder
- Keywords
- mVSD Occluder, mVSD, Occlutech, Occlutech mVSD Occluder, Muscular ventricular septal defect closure, Transcatheter closure, Percutaneous occlusion, Periventricular closure, Post-market clinical follow-up, PMCF, Congenital heart defect, Structural heart disease intervention, Echocardiography follow-up
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlutech muscular ventricular septal defect (mVSD) OccluderDevice
Percutaneous, transcatheter (catheter-based) non-surgical closure of a muscular ventricular septal defect (mVSD) using the Occlutech mVSD Occluder. The device is a self-expandable nitinol wire-mesh occluder with two retention discs connected by a flexible waist and incorporates polyester/PET patches to support defect occlusion and tissue ingrowth. Implantation is performed by experienced operators in a specialized cath lab according to the IFU and local routine; device sizing/selection is guided by imaging (e.g., transthoracic echocardiography, angiography, fluoroscopy). The system is deployed using compatible Occlutech delivery accessories (e.g., Occlutech Pistol Pusher and Occlutech Delivery Set [ODS v1 or ODS III], as applicable).
| Study group | Role | What they receive |
|---|---|---|
| muscular ventricular septal defects | patients with muscular ventricular septal defects Receives: Device: Occlutech muscular ventricular septal defect (mVSD) Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation
Serious Adverse Device Effects (SADEs) include procedure-related death, stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, severe tricuspid regurgitation (TR), severe aortic regurgitation (AR), right ventricular outflow tract obstruction (RVOTO), left ventricular outflow tract obstruction (LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open-heart surgery.
Measured: Up to 12 months post-procedure
Percentage of Participants With Successful Device Implantation and Trivial or No Residual Ventricular Septal Shunt at 12 Months
Successful implantation of the Occlutech mVSD Occluder with effective closure defined as reduction of the muscular ventricular septal shunt to trivial or no residual shunt, as assessed by echocardiography.
Measured: 12 months post-procedure
Secondary outcomes (2)
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Between 1 and 3 Years After Occlutech mVSD Implantation
Incidence of Serious Adverse Device Effects (SADEs) occurring more than 1 year and up to 3 years after the procedure, including procedure-related death, stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, severe TR, severe AR, RVOTO, LVOTO, device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open-heart surgery.
Measured: 1 year to 3 years post-procedure
Percentage of Participants With Minor Complications, Including Transient Hemolysis and Non-Surgical Vascular Complications, Up to 3 Years
Minor complications include transient hemolysis, vascular complications not requiring surgery, and other clinically relevant minor complications as assessed by the investigator.
Measured: Up to 3 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start3 Mar 2022
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular 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
- Prospective
- 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
- NCT05329350
- Sponsor's protocol ID
- Occ2016_07
- Acronym
- mVSD Registry
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2018
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 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® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects
- ClinicalTrials.gov ID
- NCT05329350
- Acronym / sponsor ID
- mVSD Registry / Occ2016_07
- Conditions
- Muscular Ventricular Septal Defect
- Keywords
- mVSD Occluder, mVSD, Occlutech, Occlutech mVSD Occluder, Muscular ventricular septal defect closure, Transcatheter closure, Percutaneous occlusion, Periventricular closure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 15 Apr 2022 (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 Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
The objectives of the study are:
- To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
- To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
Detailed description
This is a multicenter, prospective, and retrospective, international, post-market clinical follow-up Study to monitor the efficacy and safety of the Occlutech mVSD in patients with muscular ventricular septal defects.
Safety and efficacy of implanted devices are assessed by echocardiography, vital signs, laboratory tests, and ECGs on Day 1 (within 48 hours post-procedure), follow-up 1 (between Day 30 and Day 60), follow-up 2 at 6 months (from Day 61 until 6 months), follow-up 3 at 1 year (from 6 months until 1 year), and follow-up 4 at 3 years (from 1 year until 3 years).
- Patients will be screened to determine eligibility for the registry based on inclusion/exclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.
- Participants are treated according to the instructions-for-use (IFU) of the device and according to clinical routine.
- Procedures are performed at sites having appropriate laboratory support and adequately trained imaging personnel. The procedure is performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transcatheter patent ductus arteriosus, atrial septal defect, and ventricular septal defect (VSD) closures.
Recruitment will be open until 50 Patients have been enrolled. The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.
The primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| muscular ventricular septal defects | – | Device: Occlutech muscular ventricular septal defect (mVSD) Occluderpatients with muscular ventricular septal defects |
Who may qualify
- Ages
- 3 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients of any age with a hemodynamically or clinically significant muscular ventricular septal defect (mVSD) who are candidates for non-surgical closure with the Occlutech mVSD Occluder in routine clinical practice (predominantly pediatric patients). Eligibility is confirmed based on protocol-defined inclusion/exclusion criteria and baseline clinical assessment, including medical history, demographics, vital signs, ECG and echocardiography; laboratory tests may be performed according to local standard of care.
Key inclusion criteria (13 listed)
- A participant will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
- Any age
- Male or female.
- Patients understand the nature of the study and provide their informed consent to participation.
- Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
Key exclusion criteria (15 listed)
- ⦁Active bacterial infections
- Active infection at the time of implantation
- Allergy to antiplatelet or anticoagulant therapy
- Allergy to nickel and/or titanium and/or nickel/titanium-based materials
- Any type of serious infection 1 month before the procedure
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 |
|---|---|---|
| Occlutech muscular ventricular septal defect (mVSD) OccluderPercutaneous, transcatheter (catheter-based) non-surgical closure of a muscular ventricular septal defect (mVSD) using the Occlutech mVSD Occluder. The device is a self-expandable nitinol wire-mesh occluder with two retention discs connected by a flexible waist and incorporates polyester/PET patches to support defect occlusion and tissue ingrowth. Implantation is performed by experienced operators in a specialized cath lab according to the IFU and local routine; device sizing/selection is guided by imaging (e.g., transthoracic echocardiography, angiography, fluoroscopy). The system is deployed using compatible Occlutech delivery accessories (e.g., Occlutech Pistol Pusher and Occlutech Delivery Set [ODS v1 or ODS III], as applicable). | Device | muscular ventricular septal defects |
Primary outcome
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation
Time frame: Up to 12 months post-procedure
Serious Adverse Device Effects (SADEs) include procedure-related death, stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, severe tricuspid regurgitation (TR), severe aortic regurgitation (AR), right ventricular outflow tract obstruction (RVOTO), left ventricular outflow tract obstruction (LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open-heart surgery.
Percentage of Participants With Successful Device Implantation and Trivial or No Residual Ventricular Septal Shunt at 12 Months
Time frame: 12 months post-procedure
Successful implantation of the Occlutech mVSD Occluder with effective closure defined as reduction of the muscular ventricular septal shunt to trivial or no residual shunt, as assessed by echocardiography.
2 secondary outcomes
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Between 1 and 3 Years After Occlutech mVSD Implantation
Time frame: 1 year to 3 years post-procedure
Percentage of Participants With Minor Complications, Including Transient Hemolysis and Non-Surgical Vascular Complications, Up to 3 Years
Time frame: Up to 3 years post-procedure
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 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Ventricular Septal Defect, run by Occlutech International AB at 6 sites in 3 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 13 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 30 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 6 sites in Turkey (Türkiye), Ireland, United Kingdom. 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?
Contact Ahmed Dellaa (+49 151 14139961, ahmed.dellaa@occlutech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation (time frame: Up to 12 months post-procedure). 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 30 Jul 2026.