CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device (CAN-DETECT)

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.

Study Overview

• Status: Unknown
• Conditions: Arrhythmias, Cardiac

• Study Type: Observational
• Enrollment (Anticipated): 101

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6L 5X8
      • Recruiting
      • Grey-Nuns and Royal-Alexandra Hospitals
      • Contact: Sajad Gulamhusein, MD; Phone Number: 780-735-7739; Email: sajadgulamhusein@gmail.com
      • Contact: Diane Beaudette, RN; Phone Number: 780-735-7135; Email: dbeaudette@shaw.ca
      • Principal Investigator: Sajad Gulamhusein, MD
      • Sub-Investigator: Randall Williams, MD
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • Recruiting
      • Hôtel-Dieu
      • Contact: Martine Bergeron, RN; Phone Number: 12792 514 890 8000; Email: Martine.Bergeron@crchum.qc.ca
      • Contact: Denise Fournier; Phone Number: 12795 514 890 8000; Email: denise.fournier.chum@ssss.gouv.qc.ca
    • Montreal, Quebec, Canada
      • Recruiting
      • Hopital du Sacre-Coeur
      • Contact: Marcio Sturmer, MD; Phone Number: 3722 (514)-338-2222
      • Contact: Ann Langlois; Phone Number: 3722 (514)-338-2222; Email: A-Langlois@crhsc.rtss.qc.ca
    • Montreal, Quebec, Canada
      • Active, not recruiting
      • ICM
    • Sherbrooke, Quebec, Canada
      • Recruiting
      • CHUS
      • Contact: Felix Ayala-Paredes, MD; Phone Number: 14 326 1819 346 1110; Email: Felix.Ayala-Paredes@USherbrooke.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Exclusion Criteria:

Any patient complying with any of the following criteria cannot be included in the CAN-DETECT study:

1. Any contraindication for standard cardiac pacing
2. Any contraindication for ICD therapy
3. Permanent high-degree AV Block for patients planned for dual-chamber ICD implant only.
4. Permanent AF for patients planned for dual-chamber ICD implant only.
5. Abdominal implantation site
6. Acute myocarditis
7. Mechanical tricuspid valve
8. Heart transplant recipient
9. Already participating in another clinical study
10. Life expectancy less than 6 months
11. Inability to understand the purpose of the study or refusal to cooperate
12. Inability or refusal to provide informed consent
13. Unavailability for scheduled follow-up at the implanting center
14. Under guardianship
15. Age of less than 18 years.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sorin Group Canada
• Investigators: Principal Investigator: Marcio Sturmer, MD, Hopital du Sacre-Coeur, Montreal, Qc, Canada; Principal Investigator: Bernard Thibault, MD, MHI, Montreal, Qc, Canada

Study record dates

Study Major Dates

• Study Start: April 1, 2010

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): June 13, 2011
• Last Update Submitted That Met QC Criteria: June 10, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Efficacy; Sensitivity; Cardiac Event recorder
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: ITHO02