We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01694394
Recruitment Status : Unknown
Verified September 2015 by Jeff Healey, Population Health Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Device: Implantable Cardiac Monitor (Confirm(R)ICM model 2102) Phase 4

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
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)
Study Start Date : December 2012
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. First atrial fibrillation episode at least 5 minutes in duration [ Time Frame: over maximum follow-up of 18 months ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694394

Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Canada, Manitoba
St. Boniface Hospital
Winnepeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Queen Elizabeth-II Heather Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton Health Sciences - Electrophysiology Clinic
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Sciences - Interventional Cardiology
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Sciences - Perioperative Ischemia Research Group
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Center University Hospital
London, Ontario, Canada, N6A 5A5
Southlake Regional HealthCare
Newmarket, Ontario, Canada, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, 613-761-5208
Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H9S 1H4
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hopital Laval)
Sainte-Foy, Quebec, Canada, G1V 4G5
Academisch Medisch Centrum (AMC) Amsterdam
Amsterdam, Netherlands, 1100 DD
Amphia Hospital
Breda, Netherlands, 4818 CK
Nij Smellinge
Drachten, Netherlands, 9202 DA
Groene Hart Ziekenhuis Gouda
Gouda, Netherlands, 2803 HH
Diakonessenhuis Leiden
Leiden, Netherlands, 2334 CK
Ikazia Hospital
Rotterdam, Netherlands, 3083 AN
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

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
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Jeff Healey, 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