Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
|ClinicalTrials.gov Identifier: NCT00890799|
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : February 5, 2013
|Condition or disease||Intervention/treatment|
|Ventricular Septal Defects||Device: Shanghai pmVSD occluder Procedure: surgery|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects|
|Study Start Date :||June 2007|
|Primary Completion Date :||December 2010|
|Study Completion Date :||July 2012|
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Device: Shanghai pmVSD occluder
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Other Name: Shanghai pmVSD-OProcedure: surgery
Patient in this group received open surgical repair of pmVSD.
Other Name: open surgery
- Major adverse events [ Time Frame: till study end ]Major adverse events included but were not limited to death during or after the procedure because of complications of the procedure,cAVB requiring pacemaker implantation, thromboembolism, and new-onset valvular regurgitation requiring surgical repair.
- Minor adverse events [ Time Frame: Till study end ]Minor adverse events included but were not limited to groin hematoma, blood loss requiring transfusion, device embolization with transcatheter removal, any cardiac arrhythmia that required medication, new or increased valvular regurgitation less than two grades, hemolysis requiring medication, fever >38.5°C, rash, and loss of peripheral pulse. These minor adverse events required medical intervention but were not life threatening; they had no long-term sequelae and did not require long-term therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890799
|Principal Investigator:||Jian Yang, M.D., Ph. D.||Xijing Cardiovascular Hospital|