Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT05329350
Eligibility Criteria:
Inclusion Criteria:
A patient will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. Thus, the Occlutech® mVSD is indicated percutaneous, transcatheter muscular ventricular septal defect closure and who are deemed at high risk for surgical intervention after consultation with surgical physicians or as an alternative to surgery with less operational time and recovery period.
Exclusion Criteria:
The device is contraindicated for patients known to have any of the following:
* An aortic rim of less than 2 mm
* Patients weighing less than 5.0 kg
* Sepsis (local or generalized)
* Perimembranous VSD or post-MI VSD
* Recent myocardial infarction or a surgical bypass operation in the last 30 days
* History of repeated pulmonary infection
* Any type of serious infection 1 month prior to procedure
* Malignancy where life expectancy is less than 3 years
* Demonstrated intracardiac thrombi on echocardiography
* Allergy to anti-platelet or anticoagulant therapy
* Allergy to nickel and/or titanium and/or nickel/titanium-based materials
* Intolerance to contrast agents
* Active bacterial infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
80 Years
Study:
NCT05329350
Study Brief:
Protocol Section:
NCT05329350