Arrhythmias, CardiacCAN-DETECTNCT01218763
CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device
An observational study of Arrhythmias, Cardiac, run by Sorin Group Canada at 5 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmias, Cardiac
- How many people
- 101 participants
- Where
- 5 sitesCanada
- Study dates
- Apr 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 4 recruiting
- Recruiting
Grey-Nuns and Royal-Alexandra Hospitals
Edmonton, Alberta, T6L 5X8
Sajad Gulamhusein, MD, 780-735-7739, sajadgulamhusein@gmail.com
Diane Beaudette, RN, 780-735-7135, dbeaudette@shaw.ca
- Recruiting
Hotel-Dieu
Montreal, Quebec, H2W 1T8
Martine Bergeron, RN, 514 890 8000 ext. 12792, Martine.Bergeron@crchum.qc.ca
Denise Fournier, 514 890 8000 ext. 12795, denise.fournier.chum@ssss.gouv.qc.ca
- Recruiting
Hopital du Sacre-Coeur
Montreal, Quebec
Marcio Sturmer, MD, (514)-338-2222 ext. 3722
Ann Langlois, (514)-338-2222 ext. 3722, A-Langlois@crhsc.rtss.qc.ca
- Active, not recruiting
ICM
Montreal, Quebec
- Recruiting
CHUS
Sherbrooke, Quebec
Felix Ayala-Paredes, MD, 1819 346 1110 ext. 14 326, Felix.Ayala-Paredes@USherbrooke.ca
About this study
Official title: 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).
Read more
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
- Medical subject headings
- Arrhythmias, Cardiac, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorin Group Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marcio Sturmer, MD, Principal investigator, Hopital du Sacre-Coeur, Montreal, Qc, CanadaBernard Thibault, MD, Principal investigator, MHI, Montreal, Qc, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218763
- Sponsor's protocol ID
- ITHO02
- Acronym
- CAN-DETECT
- Status last verified
- Apr 2010
- First submitted
- 8 Oct 2010
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device
- ClinicalTrials.gov ID
- NCT01218763
- Acronym / sponsor ID
- CAN-DETECT / ITHO02
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Cardiac Event recorder, Sensitivity, Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Sorin Group CanadaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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 .
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VT/VF sensitivity
Time frame: 2 years
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.
1 secondary outcome
AF sensitivity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcio Sturmer, MD principal investigator
Hopital du Sacre-Coeur, Montreal, Qc, Canada
Bernard Thibault, MD principal investigator
MHI, Montreal, Qc, Canada
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Sorin Group Canada at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT/VF sensitivity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.