Status:
UNKNOWN
CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device
Lead Sponsor:
Sorin Group Canada
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
Brief Summary
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 SpiderFla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01218763
Start Date
April 1 2010
Last Update
June 13 2011
Active Locations (5)
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1
Grey-Nuns and Royal-Alexandra Hospitals
Edmonton, Alberta, Canada, T6L 5X8
2
Hotel-Dieu
Montreal, Quebec, Canada, H2W 1T8
3
Hopital du Sacre-Coeur
Montreal, Quebec, Canada
4
ICM
Montreal, Quebec, Canada