Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 6:52 AM
Study NCT ID:
NCT05329350
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2018-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Sponsor:
Occlutech International AB
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mVSD Registry
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 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.
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.
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 implanted device(s) will be assessed by vital signs, laboratory test, ECGs, and echocardiography on Day 1 (within 36 hrs. post procedure), Day 30, day 60, 6 months and 1 year after the implantation.
* Patients will be treated according to the instruction-for-use of the device and according to clinical routine
* Patients will be screened to determine eligibility for the registry based on inclusion/exclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.
* Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedure will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transseptal puncture, anterograde, retrograde or transapical device delivery approaches.
Registry will be open for the next two years or when up to 100 patients are enrolled (whatever comes first)
The primary efficacy endpoints will include data obtained 1 year after mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as Reduction in muscular ventricular septal regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
The primary safety endpoint is defined as absence of Serious Adverse Events (SAEs) 1 years after mVSD closure procedure.
* Efficacy and safety of implanted device(s) will be assessed by vital signs, laboratory test, ECGs, and echocardiography on Day 1 (within 36 hrs. post procedure), Day 30, day 60, 6 months and 1 year after the implantation.
* Patients will be treated according to the instruction-for-use of the device and according to clinical routine
* Patients will be screened to determine eligibility for the registry based on inclusion/exclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.
* Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedure will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transseptal puncture, anterograde, retrograde or transapical device delivery approaches.
Registry will be open for the next two years or when up to 100 patients are enrolled (whatever comes first)
The primary efficacy endpoints will include data obtained 1 year after mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as Reduction in muscular ventricular septal regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
The primary safety endpoint is defined as absence of Serious Adverse Events (SAEs) 1 years after mVSD closure procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: