CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device

Study Overview
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Brief Summary
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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.

Official Title
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CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device

Conditions
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Arrhythmias, Cardiac

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Patient is eligible for implantation of a dual-chamber ICD or a CRT-D device according to current available guidelines for primary or secondary ICD indication . A stable, optimal (as determined by the enrolling physician) drug regimen Scheduled for implant of an OVATIO DR Model 6550 or OVATIO CRT 6750 or an equivalent device from Sorin Group. Signed and dated informed consent. Exclusion Criteria: Any patient complying with any of the following criteria cannot be included in the CAN-DETECT study: Any contraindication for standard cardiac pacing Any contraindication for ICD therapy Permanent high-degree AV Block for patients planned for dual-chamber ICD implant only. Permanent AF for patients planned for dual-chamber ICD implant only. Abdominal implantation site Acute myocarditis Mechanical tricuspid valve Heart transplant recipient Already participating in another clinical study Life expectancy less than 6 months Inability to understand the purpose of the study or refusal to cooperate Inability or refusal to provide informed consent Unavailability for scheduled follow-up at the implanting center Under guardianship Age of less than 18 years.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD patients<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VT/VF sensitivity | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF sensitivity | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Event recorder, Sensitivity, Efficacy