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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-tâ„¢ Event recorder coupled with its analyser EventScopeâ„¢, 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 EventScopeâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 EventScopeâ„¢ analyzer found in the Holter monitor SpiderFlash-tâ„¢. 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 |
| 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 EventScopeâ„¢ in patients presenting with a spontaneous rhythm. SafeR mode, programmed in DR devices, will permit preservation of such rhythm. |
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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:
Exclusion Criteria:
Any patient complying with any of the following criteria cannot be included in the CAN-DETECT study:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marcio Sturmer, MD | Hopital du Sacre-Coeur, Montreal, Qc, Canada | Principal Investigator |
| Bernard Thibault, MD | MHI, Montreal, Qc, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grey-Nuns and Royal-Alexandra Hospitals | Recruiting | Edmonton | Alberta | T6L 5X8 | Canada |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 2 years |
| Hotel-Dieu | Recruiting | Montreal | Quebec | H2W 1T8 | Canada |
|
| Hopital du Sacre-Coeur | Recruiting | Montreal | Quebec | Canada |
|
| ICM | Active, not recruiting | Montreal | Quebec | Canada |
| CHUS | Recruiting | Sherbrooke | Quebec | Canada |
|
| D007154 | Immune System Diseases |