Occlutech mVSD for Muscular Ventricular Septal Defect
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Recruiting
Observational Study
Muscular Ventricular Septal Defect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 Months – 80
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Occlutech International AB · Industry
Who this trial is looking for
This trial is looking for patients needing treatment for muscular ventricular septal defects. Participants will receive the Occlutech mVSD device and will need to attend follow-up visits.
Are You a Good Fit for This Trial?
Rules you outActive bacterial infectionsSepsisRecent myocardial infarction
You may be able to join if
I have a muscular ventricular septal defect.
I am any age.
I am male or female.
I understand the study and agree to participate.
I can attend follow-up visits.
You may not be able to join if
I have a serious bacterial infection.
I have had a heart attack or bypass surgery in the last 30 days.
I have significant issues with my heart size.
I have an allergy to certain metal materials.
I have a diameter of VSD greater than 20 mm.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 occlu…
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.
Trial Locations
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Status
Eligibility Criteria
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.
* …
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
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