Status:
RECRUITING
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Lead Sponsor:
Occlutech International AB
Conditions:
Muscular Ventricular Septal Defect
Eligibility:
All Genders
3-80 years
Brief Summary
The Occlutech® mVSD is indicated for percutaneous, transcatheter muscular ventricular septal defect closure device designed for the occlusion of hemodynamically significant muscular ventricular septal...
Detailed Description
This is a multicenter, International, follow-up registry to monitor the efficacy and safety of the Occlutech® mVSD in patients with muscular ventricular septal defects. * Efficacy and safety of impla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05329350
Start Date
March 3 2022
End Date
October 1 2029
Last Update
February 14 2024
Active Locations (1)
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1
Gaziantep Unıversıty Hospital
Gaziantep, Şehitkamil, Turkey (Türkiye), 27310