Actively Recruiting
A Multicenter, International Follow-up Study to Monitor the Efficacy and Safety of the Occlutech4 Muscular Ventricular Septal Defect Occluder in Patients With Muscular Ventricular Septal Defects
Led by Occlutech International AB · Updated on 2026-02-02
50
Participants Needed
5
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Occlutech4 muscular ventricular septal defect (mVSD) Occluder for patients who have significant muscular ventricular septal defects. This international, multicenter follow-up study aims to confirm the device's safety and effectiveness in closing these heart defects using a catheter-based, minimally invasive procedure. The study includes both prospective and retrospective patients and is sponsored by Occlutech International AB. The Occlutech mVSD Occluder is a self-expanding device made of nitinol wire mesh with polyester patches to support defect closure and tissue growth. Experienced doctors implant the device through a catheter in a specialized cardiac lab, using imaging techniques like echocardiography and fluoroscopy to guide placement. Participants receive treatment according to device instructions and clinical routine. Follow-up visits are scheduled at 1 to 48 hours after the procedure, 30 to 60 days, 6 months, 1 year, and up to 3 years. Participants undergo safety and effectiveness assessments including echocardiography, vital signs, lab tests, and ECGs during these follow-ups. Key safety outcomes include monitoring for serious device-related complications such as heart block, device embolization, or infections within one year. Effectiveness is measured by the successful closure of the defect assessed by echocardiography at one year. The study is open to patients from 3 months to 80 years old who meet eligibility criteria and can attend all scheduled visits.
CONDITIONS
Brief Title
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet the indication and use area described in the device instructions-for-use for percutaneous occlusion of significant muscular ventricular septal defects.
- Any age is considered.
- Male or female.
- Patients must understand the study and provide informed consent.
- Patients must be willing and able to attend all scheduled follow-up visits and procedures.
You will not qualify if you...
- Hemodynamically relevant ventricular septal defect shunt.
- Congestive heart failure.
- Recurrent respiratory infections.
- Failure to thrive.
- Significant enlargement of left ventricle or left atrium.
- Other clinical indications contraindicating participation.
- Active bacterial infection at implantation time.
- Allergy to antiplatelet or anticoagulant therapy.
- Allergy to nickel, titanium, or nickel/titanium-based materials.
- Serious infection within 1 month before procedure.
- Aortic rim less than 2 mm.
- Intracardiac thrombi detected by echocardiography.
- Life expectancy less than 3 years due to malignancy.
- Muscular ventricular septal defect diameter greater than 20 mm.
- Perimembranous ventricular septal defect.
- Recent myocardial infarction or surgical bypass within last 30 days.
- Local or generalized sepsis.
- Septal thickness greater than 7 mm at occluder placement area.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1 (within 48 hours post-procedure)
Participants undergo implantation of the Occlutech muscular ventricular septal defect (mVSD) Occluder device by experienced operators in a specialized catheterization laboratory according to device instructions and local routine care.
1 visit (in-person)
Duration - From Day 30 up to 3 years
Participants are monitored for safety and efficacy through echocardiography, vital signs, laboratory tests, and ECGs at multiple follow-up time points after device implantation.
Approximately 5 follow-up visits (between Day 30 and 3 years)
Trial Site Locations
Total: 5 locations
1
Children's Health Ireland
Dublin, Ireland, N512
Not Yet Recruiting
2
İzmir Şehir Hastanesi
Izmir, Bayraklı, Turkey (Türkiye), 35540
Not Yet Recruiting
3
Eskişehir Osmangazi Üniversite Hastanesi
Eskişehir, Odunpazarı, Turkey (Türkiye), 26040
Not Yet Recruiting
4
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Sur, Turkey (Türkiye)
Not Yet Recruiting
5
Gaziantep Unıversıty Hospital
Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
Actively Recruiting
Research Team
A
Ahmed Della
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Frequently Asked Questions
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