CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device (CAN-DETECT)
Recruitment status was: Recruiting
This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.
This trial aims to validate the automatic detection features provided by the external long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to assess the performances of the Mode Switch function provided by Sorin Group Implantable Cardioverter-Defibrillators (ICDs).
This trial is being performed first in order to demonstrate the ventricular tachycardia (VT)/ ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of the EventScope™ software.
Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection enabled and Mode Switch (MS) algorithms activated in all patients.
Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device|
- VT/VF sensitivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]The primary purpose of this study is to evaluate the performance of the automatic detection of ventricular tachycardia and ventricular fibrillation (VT/VF) by the EventScope™ analyzer found in the Holter monitor SpiderFlash-t™. In order to validate this objective we will use the arrhythmia data collected in the memory storage found in the Sorin Group DR and CRT ICDs.
- AF sensitivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]The main secondary objective of this study is to evaluate the detection of atrial fibrillation by the Mode Switch algorithm found in the Sorin Group defibrillators. However, as SpiderFlash-t has only been validated on patients with spontaneous rhythm, in order to achieve this objective we will use the AF events detected by the EventScope™ in patients presenting with a spontaneous rhythm. SafeR mode, programmed in DR devices, will permit preservation of such rhythm.
|Study Start Date:||April 2010|
Candidates may come from the investigator's general population, who require DR ICD or CRT-D therapy for primary or secondary ICD indication and meet all study eligibility criteria
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218763
|Grey-Nuns and Royal-Alexandra Hospitals|
|Edmonton, Alberta, Canada, T6L 5X8|
|Montreal, Quebec, Canada, H2W 1T8|
|Hopital du Sacre-Coeur|
|Montreal, Quebec, Canada|
|Montreal, Quebec, Canada|
|Sherbrooke, Quebec, Canada|
|Principal Investigator:||Marcio Sturmer, MD||Hopital du Sacre-Coeur, Montreal, Qc, Canada|
|Principal Investigator:||Bernard Thibault, MD||MHI, Montreal, Qc, Canada|