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

This study is ongoing, but not recruiting participants.
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 21, 2015
Last verified: September 2015
  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: December 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (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   (Adult, Senior)
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

Locations
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
Netherlands
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)
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

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 21, 2015
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 July 28, 2016