NCT05329350 Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
| NCT ID | NCT05329350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Occlutech International AB |
| Condition | Muscular Ventricular Septal Defect |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2031-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-03-03 with a primary completion date of 2031-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05329350 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 80 Years, studying Muscular Ventricular Septal Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05329350 currently recruiting?
Yes, NCT05329350 is actively recruiting participants. Contact the research team at ahmed.dellaa@occlutech.com for enrollment information.
Where is the NCT05329350 trial being conducted?
This trial is being conducted at Dublin, Ireland, Izmir, Turkey (Türkiye), Eskişehir, Turkey (Türkiye), Diyarbakır, Turkey (Türkiye) and 2 additional locations.
Who is sponsoring the NCT05329350 clinical trial?
NCT05329350 is sponsored by Occlutech International AB. The trial plans to enroll 50 participants.