CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device (CAN-DETECT)
Recruitment status was Recruiting
|First Received Date ICMJE||October 8, 2010|
|Last Updated Date||June 10, 2011|
|Start Date ICMJE||April 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01218763 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device|
|Official Title ICMJE||CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device|
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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
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.
|Condition ICMJE||Arrhythmias, Cardiac|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||ICD patients
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
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||101|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients already implanted with an OVATIO DR or CRT-D device may be included in the study if they presented with at least one clinical VT/VF event at the follow-up visit preceding the enrolment.
ICD or CRT-D device upgrading or replacement are allowed but under the condition that existing bipolar RV sensing/pacing lead and/or defibrillation lead and/or LV pacing lead (where applicable) are not of poor or questionable integrity.
Patients with implanted pacemakers may be included in the study only if the pacemaker is to be explanted or otherwise disabled prior to implanting the ICD or CRT-D system, to avoid any potential pacemaker-ICD interactions.
Patients must comply with all the following criteria in order to be included in the CAN-DETECT study:
Any patient complying with any of the following criteria cannot be included in the CAN-DETECT study:
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Not Provided|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT01218763|
|Other Study ID Numbers ICMJE||ITHO02|
|Has Data Monitoring Committee||No|
|Responsible Party||Marcio Sturmer, MD, Hopital du Sacre-Coeur, Montreal, Quebec|
|Study Sponsor ICMJE||Sorin Group Canada|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Sorin Group Canada|
|Verification Date||April 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP