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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 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: March 24, 2015
Last verified: March 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: July 2016
Estimated Primary Completion Date: April 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
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: Kim Simek 905-527-4322 ext 40524 Kim.Simek@phri.ca
Contact: Angie Djuric 905-527-4322 ext 40545 angie.djuric@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 Recruiting
Winnepeg, Manitoba, Canada, R2H 2A6
Contact: Jan Polson    204-258-1267    JMPolson@sbgh.mb.ca   
Principal Investigator: Colette Seifer, M.D.         
Canada, Nova Scotia
Queen Elizabeth-II Heather Sciences Center Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Karen Giddens    902-473-2758    Karen.Giddens@cdha.nshealth.ca   
Contact: Mallory Harris    902-473-2758    Mallory.Harris@cdha.nshealth.ca   
Principal Investigator: Nicolas Giacomantonio, M.D.         
Sub-Investigator: Ratika Parkash, M.D.         
Canada, Ontario
Hamilton Health Sciences - Perioperative Ischemia Research Group Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Krysten Gregus    905-521-2100 ext 67177    gregus@hhsc.ca   
Principal Investigator: Philip J Devereaux, M.D.         
Hamilton Health Sciences - Interventional Cardiology 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 - Electrophysiology Clinic Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Victoria Malcolm    905-527-4322 ext 44506    malcolmv@hhsc.ca   
Principal Investigator: Carlos Morillo, M.D.         
London Health Sciences Center University Hospital 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 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 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.         
Health Sciences North 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) Recruiting
Sainte-Foy, Quebec, Canada, G1V 4G5
Contact: Lyne Charbonneau    418-656-8711 ext 5828    lyne.charbonneau@criucpq.ulaval.ca   
Contact: Paule Banville    418-656-8711 ext 2132    paule.banville@criucpq.ulaval.ca   
Principal Investigator: Francois Philippon, M.D.         
Sub-Investigator: Raymond Labbe, M.D.         
Netherlands
Academisch Medisch Centrum (AMC) Amsterdam Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: Ineke Radder    +31 20 5668 673    j.m.radder@amc.uva.nl   
Principal Investigator: Joris De Groot, M.D.         
Amphia Hospital Recruiting
Breda, Netherlands, 4818 CK
Contact: Ineke Hunze    31765954164    ihunze@amphia.nl   
Principal Investigator: Marco Alings, M.D.         
Nij Smellinge Recruiting
Drachten, Netherlands, 9202 DA
Contact: Geert Post    31-0-512-588191    g.post@nijsmellinghe.nl   
Principal Investigator: Jaap De Graaf, M.D.         
Groene Hart Ziekenhuis Gouda Recruiting
Gouda, Netherlands, 2803 HH
Contact: Hanneke Kramer    +31 182 5053 60    hanneke.kramer@ghz.nl   
Principal Investigator: Eric Viergever, M.D.         
Diakonessenhuis Leiden Recruiting
Leiden, Netherlands, 2334 CK
Contact: Joyce Witteman    071-5178433    jwitteman@diaconessenhuis.nl   
Contact: Eina Kerssen Pols    071-5178433    ekerssen@diaconessenhuis.nl   
Principal Investigator: T.J. Römer, M.D.         
Ikazia Hospital Recruiting
Rotterdam, Netherlands, 3083 AN
Contact: Petra den Boer    +31 102 975 485    researchcardiologie@ikazia.nl   
Principal Investigator: Michel Freericks, 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: March 24, 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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 01, 2015