At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 129 enrolled
Drug / intervention
Single Site Pacing +1 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.
Post-Myocardial Infarction Remodeling Prevention Therapy
In Brief
A Phase 2 clinical trial evaluating Single Site Pacing and Dual Site Pacing for Acute Myocardial Infarction and 3 related conditions. Completed, enrolled 129 participants across 26 sites in 7 countries.
Detailed Summary
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, France, Germany, Hungary, Saudi Arabia, Slovakia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartDec 2010
Primary CompletionOct 2015
Study CompletionApr 2016
TodayJul 2026
First PostedOct 1, 2010
Enrollment StartDec 1, 2010
Primary CompletionOct 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.8 years ago
Interventions
Single Site Pacingdevice
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site Pacingdevice
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.