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
St. Jude Medical
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jeff Healey, Population Health Research Institute Identifier:
First received: September 23, 2012
Last updated: September 26, 2012
Last verified: September 2012

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
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


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


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 identifier: NCT01694394

Contact: Heather J Beresh, M.Sc. 905-527-4322 ext 40351
Contact: Ellison Themeles, M.Sc. 905-527-4322 ext 40488

Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Carol Kenney    403-944-4286   
Contact: Michelle Wright    403-944-4286   
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   
Principal Investigator: Colette Seifer, M.D.         
Canada, Ontario
Hamilton Health Sciences - Perioperative Ischemia Research Group Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Krysten Gregus    905-521-2100 ext 67177   
Principal Investigator: Philip J Devereaux, M.D.         
Hamilton Health Sciences - Electrophysiology Clinic Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Victoria Malcolm    905-527-4322 ext 44506   
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   
Principal Investigator: Shamir Mehta, M.D.         
London Health Sciences Center University Hospital Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Kathy Blackler    519-663-3746   
Principal Investigator: Peter Leong-Sit, M.D.         
Southlake Regional HealthCare Not yet recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Annette Nath    905-953-7917   
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   
Contact: Rochelle Fleming    613-798-5555 ext 18608   
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   
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   
Principal Investigator: Atilio Costa-Vitali, M.D.         
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Ann Hill    416-340-4339   
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   
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)
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 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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on October 22, 2014