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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Sorin Group Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sorin Group Canada
ClinicalTrials.gov Identifier:
NCT01218763
First received: October 8, 2010
Last updated: June 10, 2011
Last verified: April 2010
  Purpose

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.


Condition
Arrhythmias, Cardiac

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device

Resource links provided by NLM:


Further study details as provided by Sorin Group Canada:

Primary Outcome Measures:
  • VT/VF sensitivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • AF sensitivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 101
Study Start Date: April 2010
Groups/Cohorts
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218763

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

No publications provided

Responsible Party: Marcio Sturmer, MD, Hopital du Sacre-Coeur, Montreal, Quebec
ClinicalTrials.gov Identifier: NCT01218763     History of Changes
Other Study ID Numbers: ITHO02
Study First Received: October 8, 2010
Last Updated: June 10, 2011
Health Authority: Canada: Health Canada

Keywords provided by Sorin Group Canada:
Cardiac Event recorder
Sensitivity
Efficacy

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014