NCT04034498|Active Not Recruiting
Loading search results
Sponsor study identifier
observational
50
4 countries
8
Study Start
July 7, 2019
Actual (reported)Primary Completion
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2019
Actual (reported)July 18, 2019
Actual (reported)July 26, 2019
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).
1 year following implantation
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.
1 year following implantation
There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician
Children Health Ireland
Dublin, Ireland
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
Prince of Songkla University
Hat Yai, Thailand
Osmangazi University Faculty of Medicine Hospital
Eskişehir, 26040, Turkey (Türkiye)
Gaziantep University Hospital
Gaziantep, Turkey (Türkiye)
Izmir University of Health Sciences Tepecik Training and Research Hospital
Izmir, 35020, Turkey (Türkiye)
Kocaeli University Research and Application Hospital
Kocaeli, 41001, Turkey (Türkiye)
First Submitted
July 18, 2019
First Posted
July 26, 2019
Study Start
July 7, 2019
Actual (reported)Primary Completion
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
City Children Hospital
Ho Chi Minh City, Vietnam
Study Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2026
Record last verified: 2026-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: