Actively Recruiting
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Led by Occlutech International AB · Updated on 2026-02-02
50
Participants Needed
5
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Indicated for percutaneous closure of hemodynamically or clinically significant muscular ventricular septal defects as per device instructions
- Any age
- Male or female
- Understands the study and provides informed consent
- Willing and able to attend all follow-up visits and procedures required by the study
You will not qualify if you...
- Hemodynamically relevant VSD shunt
- Congestive heart insufficiency
- Recurrent respiratory infections
- Failure to thrive
- Significant left ventricle enlargement
- Significant left atrium enlargement
- Active bacterial infection at implantation
- 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 seen on echocardiography
- Malignancy with life expectancy under 3 years
- mVSD diameter greater than 20 mm
- Perimembranous VSD
- Recent myocardial infarction or bypass surgery within 30 days
- Local or generalized sepsis
- Septal thickness greater than 7 mm at device placement area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here