Left Ventricular Capture Management Study (LEARN)
To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.
This is a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design, based on the primary objective, is an observational examination of LV thresholds over time. Daily left ventricular threshold measurements will be collected using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary objective at up to 15 study centers.
Data will be collected at Baseline, Implant, 12 months post-implant and all regularly scheduled follow-up visits up to 12 months post-implant.
The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM feature will be used in this study.
|Ventricular Fibrillation Ventricular Tachycardia Bradyarrhythmia|
|Study Design:||Time Perspective: Prospective|
|Official Title:||Left Ventricular Capture Management (LEARN) Study|
|Study Start Date:||October 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089634
|McGill University Health Center|
|Montreal, Quebec, Canada, H3G 1A4|
|Study Chair:||Mary McCann, R.N., MBA||Medtronic|
|Study Chair:||Allison Rubino||Medtronic|