AMPLATZER Duct Occluder II Clinical Study (ADO II)
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II|
- The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure
SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
- The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. [ Time Frame: 180 days ] [ Designated as safety issue: No ]The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||January 2017|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Device: AMPLATZER Duct Occluder II
AMPLATZER Duct Occluder II
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713700
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