Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases (mVSD Registry)

July 29, 2026 updated by: Occlutech International AB

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
      • Dublin, Ireland, N512
        • Not yet recruiting
        • Children's Health Ireland
        • Contact:
          • Claire Josephine Karungi Betz, SC
        • Contact:
          • Damien Kenny, MD
  • Turkey (Türkiye)
    • Bayraklı
      • Izmir, Bayraklı, Turkey (Türkiye), 35540
        • Not yet recruiting
        • Izmir Şehir Hastanesi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nazmi Narin, MD
        • Sub-Investigator:
          • Kaan Yıldız, Assoc. Prof. Dr., MD
    • Odunpazarı
      • Eskişehir, Odunpazarı, Turkey (Türkiye), 26040
        • Not yet recruiting
        • Eskişehir Osmangazi Üniversite Hastanesi
        • Principal Investigator:
          • Birsen Uçar, MD
        • Contact:
        • Contact:
    • Sur
      • Diyarbakır, Sur, Turkey (Türkiye)
    • Şehitkamil
      • Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
        • Recruiting
        • Gaziantep Unıversıty Hospital
        • Contact:
  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6NP
        • Not yet recruiting
        • Royal Brompton Hospital
        • Contact:
          • Prof Alain Fraisse, PI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria

  • 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

  • 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

Exclusion Criteria

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
muscular ventricular septal defects
patients with muscular ventricular septal defects
Device: Occlutech muscular ventricular septal defect (mVSD) Occluder
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months post-procedure
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.
12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
Minor complications include transient hemolysis, vascular complications not requiring surgery, and other clinically relevant minor complications as assessed by the investigator.
Up to 3 years post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occ2016_07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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