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

RECRUITINGSponsored by Occlutech International AB
Actively Recruiting
SponsorOcclutech International AB
Started2022-03-03
Est. completion2026-03-03
Eligibility
Age3 Months – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05329350

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. * To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.

Eligibility

Age: 3 Months – 80 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseaseMuscular Ventricular Septal Defect

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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