ClinicaliQ Trial Snapshot
- Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases — Recruiting • Cardiology / Cardiovascular • NCT05329350.
- Device being tested: The Occlutech® mVSD device for percutaneous (catheter-based) closure of hemodynamically or clinically significant muscular ventricular septal defects (mVSD) as an alternative to surgical intervention.
- Patient eligibility overview: Patients with muscular ventricular septal defects that are either hemodynamically significant (causing substantial blood flow abnormalities) or clinically significant (producing symptoms) and deemed suitable candidates for transcatheter closure rather than open heart surgery.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.