A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 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
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Gaziantep Unıversıty Hospital
RECRUITING
Gaziantep
Contact Information
Primary
Hussa Al Othman
hussa.alothman@occlutech.com
+49 3641 508 365
Time Frame
Start Date: 2022-03-03
Estimated Completion Date: 2029-10-01
Participants
Target number of participants: 100
Treatments
muscular ventricular septal defects
patients with muscular ventricular septal defects
Related Therapeutic Areas
Sponsors
Leads: Occlutech International AB

This content was sourced from clinicaltrials.gov