CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device

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:
• •1. 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 .
• •2. A stable, optimal (as determined by the enrolling physician) drug regimen
• •3. Scheduled for implant of an OVATIO DR Model 6550 or OVATIO CRT 6750 or an equivalent device from Sorin Group.
• •4. Signed and dated informed consent.