CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device

NCT01218763 | Unknown

• 1 other identifier: ITHO02
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Arrhythmias, Cardiac

Keywords

Cardiac Event recorder; Sensitivity; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• AF sensitivity

  2 years

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorin Group Canada: lead

Study Sites (5)

Grey-Nuns and Royal-Alexandra Hospitals

Edmonton, Alberta, T6L 5X8, Canada

RECRUITING

Hotel-Dieu

Montreal, Quebec, H2W 1T8, Canada

RECRUITING

Hopital du Sacre-Coeur

Montreal, Quebec, Canada

RECRUITING

ICM

Montreal, Quebec, Canada

ACTIVE NOT RECRUITING

CHUS

Sherbrooke, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Hypersensitivity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Marcio Sturmer, MD

  Hopital du Sacre-Coeur, Montreal, Qc, Canada

  PRINCIPAL INVESTIGATOR

• Bernard Thibault, MD

  MHI, Montreal, Qc, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: April 1, 2010
• Last Updated: June 13, 2011

Record last verified: 2010-04

Locations

CA (5)