Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Population Health Research Institute
Sponsor:
Collaborators:
St. Jude Medical
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jeff Healey, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01694394
First received: September 23, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

The primary objective of the study is to determine the rate of detection of sub-clinical atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St. Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF.


Condition Intervention Phase
Atrial Fibrillation
Device: Implantable Cardiac Monitor (Confirm(R)ICM model 2102)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patient With Cardiovascular Risk Factors (ASSERT-II)

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • First atrial fibrillation episode at least 5 minutes in duration [ Time Frame: over maximum follow-up of 18 months ] [ Designated as safety issue: No ]
    incidence of atrial fibrillation detected by continuous monitoring by an implantable cardiac monitor


Biospecimen Retention:   Samples Without DNA

Blood will be collected for NT-ProBNP and hs-Troponin-T


Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Single arm cohort will receive Implantable Cardiac Monitor for continuous monitoring over the study follow-up period to determine incidence of sub-clinical atrial fibrillation.
Device: Implantable Cardiac Monitor (Confirm(R)ICM model 2102)
Other Name: St. Jude Medical Confirm(R)ICM model 2102

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients at increased risk of atrial fibrillation and cardiovascular events but without prior history of atrial fibrillation or implanted pacemaker or defibrillator

Criteria

Inclusion Criteria

Patients will be eligible for inclusion if they meet both of the following:

  1. Age ≥ 65, plus:

    • CHA2DS2-VASc score ≥ 2 Or
    • Obstructive sleep apnea (documented by polysomnography, ambulatory oximetry, positive Berlin Questionnaire or requiring the use of CPAP/BiPAP) Or
    • BMI > 30
  2. Echocardiographic or biochemical evidence of increased risk of AF:

    • Left atrial enlargement on a clinical echocardiography at any time prior to enrollment ( defined as LA volume ≥ 58 ml or LA diameter of ≥ 4.4 cm) Or
    • Serum NT-ProBNP ≥ 290 pg/mL Exclusion Criteria

1. Previously documented history of atrial fibrillation or atrial flutter 2. Current chronic treatment with oral anticoagulation (i.e. those on peri-operative prophylaxis would be eligible) 3. Patient with implanted pacemaker or defibrillator with an atrial lead 4. Definitive plan for cardiac surgery in the next 6 months (patients who are having coronary angiography with a possibility of cardiac surgery are still eligible)

  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: NCT01694394

Contacts
Contact: Heather J Beresh, M.Sc. 905-527-4322 ext 40351 heather.beresh@phri.ca
Contact: Ellison Themeles, M.Sc. 905-527-4322 ext 40488 ellison.themeles@phri.ca

Locations
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Carol Kenney    403-944-4286    Carol.Kenney@albertahealthservices.ca   
Contact: Michelle Wright    403-944-4286    Michelle.Wright@albertahealthservices.ca   
Principal Investigator: Michael D Hill, M.D.         
Canada, Manitoba
St. Boniface Hospital Not yet recruiting
Winnepeg, Manitoba, Canada, R2H 2A6
Contact: Jan Polson    204-258-1267    JMPolson@sbgh.mb.ca   
Principal Investigator: Colette Seifer, M.D.         
Canada, Ontario
Hamilton Health Sciences - Electrophysiology Clinic Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Victoria Malcolm    905-527-4322 ext 44506    malcolmv@hhsc.ca   
Principal Investigator: Carlos Morillo, M.D.         
Hamilton Health Sciences - Interventional Cardiology Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Chris Beck    905-527-4322 ext 44152    beckc@hhsc.ca   
Principal Investigator: Shamir Mehta, M.D.         
Hamilton Health Sciences - Perioperative Ischemia Research Group Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Krysten Gregus    905-521-2100 ext 67177    gregus@hhsc.ca   
Principal Investigator: Philip J Devereaux, M.D.         
London Health Sciences Center University Hospital Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Kathy Blackler    519-663-3746    kblackle@uwo.ca   
Principal Investigator: Peter Leong-Sit, M.D.         
Southlake Regional HealthCare Not yet recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Annette Nath    905-953-7917    ANATH@southlakeregional.org   
Principal Investigator: Atul Verma, M.D.         
University of Ottawa Heart Institute Not yet recruiting
Ottawa, Ontario, Canada, 613-761-5208
Contact: Susan McClinton    613-761-5208    smcclinton@ottawaheart.ca   
Contact: Rochelle Fleming    613-798-5555 ext 18608    rfleming@ottawaheart.ca   
Principal Investigator: David Birnie, M.D.         
Principal Investigator: Richard Davies, M.D.         
Kawartha Cardiology Clinic Not yet recruiting
Peterborough, Ontario, Canada, K9J 0B2
Contact: Jen Fraser    705-743-3555    jfraser@vhn.ca   
Principal Investigator: William Hughes, M.D.         
Health Sciences North Not yet recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Cindy Bobbie    705-523-7100 ext 2488    cbobbie@hsnsudbury.ca   
Principal Investigator: Atilio Costa-Vitali, M.D.         
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Ann Hill    416-340-4339    ann.hill@uhn.on.ca   
Principal Investigator: Andrew Ha, M.D.         
Principal Investigator: Doug Cameron, M.D.         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada, H9S 1H4
Contact: Fiorella Rafti, Ph.D    514-934-1934 ext 42926    fiorella.rafti@mail.mcgill.ca   
Principal Investigator: Vidal Essebag, M.D.         
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hopital Laval) Not yet recruiting
Sainte-Foy, Quebec, Canada, G1V 4G5
Principal Investigator: Francois Philippon, M.D.         
Sub-Investigator: Raymond Labbe, M.D.         
Sponsors and Collaborators
Population Health Research Institute
St. Jude Medical
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jeff Healey, M.D. Population Health Research Institute
Principal Investigator: Stuart Connolly, M.D. Population Health Research Institute
Principal Investigator: Marco Alings, M.D. Working group Cardiovascular research Netherlands
  More Information

No publications provided

Responsible Party: Jeff Healey, Associate Professor, McMaster University, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01694394     History of Changes
Other Study ID Numbers: ASSERT-II
Study First Received: September 23, 2012
Last Updated: September 26, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Population Health Research Institute:
atrial fibrillation
implantable cardiac monitor
left atrial enlargement
CHA2DS2 VASc Score
cardiovascular risk

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

ClinicalTrials.gov processed this record on August 28, 2014