At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,500 enrolled
Drug / intervention
Standard ICD programming +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
In Brief
A clinical study evaluating Standard ICD programming, High rate cutoff, and 1 other intervention for Primary Prevention of Sudden Cardiac Arrest. Completed, enrolled 1,500 participants across 1 site.
Detailed Summary
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartSep 2009
Primary CompletionAug 2012
Study CompletionDec 2012
TodayJul 2026
First PostedJul 28, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.9 years ago
Interventions
Standard ICD programmingdevice
Standard ICD programming
High rate cutoffdevice
Programming of a high rate cutoff
Long delaydevice
Programming of a prolonged delay