Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor
ASSERT-II
1 other identifier
observational
256
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedAugust 31, 2018
August 1, 2018
3.6 years
September 23, 2012
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First atrial fibrillation episode at least 5 minutes in duration
incidence of atrial fibrillation detected by continuous monitoring by an implantable cardiac monitor
over maximum follow-up of 18 months
Study Arms (1)
Cohort
Single arm cohort will receive a St. Jude Medical Implantable Cardiac Monitor (Confirm ICM model 2102) for continuous monitoring over the study follow-up period to determine incidence of sub-clinical atrial fibrillation.
Interventions
Patients who meet the study criteria will be implanted with a St. Jude Medical Confirm Implantable Cardiac Monitor (Confirm ICM) model 2102 or other St. Jude Medical ICM with the same capabilities.
Eligibility Criteria
Patients at increased risk of atrial fibrillation and cardiovascular events but without prior history of atrial fibrillation or implanted pacemaker or defibrillator
You may qualify if:
- 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
- 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
You may not qualify if:
- \. 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Population Health Research Institutelead
- Abbott Medical Devicescollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (19)
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
St. Boniface Hospital
Winnepeg, Manitoba, R2H 2A6, Canada
Queen Elizabeth-II Heather Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton Health Sciences - Electrophysiology Clinic
Hamilton, Ontario, L8L 2X2, Canada
Hamilton Health Sciences - Interventional Cardiology
Hamilton, Ontario, L8L 2X2, Canada
Hamilton Health Sciences - Perioperative Ischemia Research Group
Hamilton, Ontario, L8L 2X2, Canada
London Health Sciences Center University Hospital
London, Ontario, N6A 5A5, Canada
Southlake Regional HealthCare
Newmarket, Ontario, L3Y 2P9, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, 613-761-5208, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
McGill University Health Centre
Montreal, Quebec, H9S 1H4, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hopital Laval)
Sainte-Foy, Quebec, G1V 4G5, Canada
Academisch Medisch Centrum (AMC) Amsterdam
Amsterdam, 1100 DD, Netherlands
Amphia Hospital
Breda, 4818 CK, Netherlands
Nij Smellinge
Drachten, 9202 DA, Netherlands
Groene Hart Ziekenhuis Gouda
Gouda, 2803 HH, Netherlands
Diakonessenhuis Leiden
Leiden, 2334 CK, Netherlands
Ikazia Hospital
Rotterdam, 3083 AN, Netherlands
Related Publications (1)
Healey JS, Alings M, Ha A, Leong-Sit P, Birnie DH, de Graaf JJ, Freericks M, Verma A, Wang J, Leong D, Dokainish H, Philippon F, Barake W, McIntyre WF, Simek K, Hill MD, Mehta SR, Carlson M, Smeele F, Pandey AS, Connolly SJ; ASSERT-II Investigators. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017 Oct 3;136(14):1276-1283. doi: 10.1161/CIRCULATIONAHA.117.028845. Epub 2017 Aug 4.
PMID: 28778946DERIVED
Biospecimen
Blood will be collected for NT-ProBNP and hs-Troponin-T
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, McMaster University
Study Record Dates
First Submitted
September 23, 2012
First Posted
September 27, 2012
Study Start
December 1, 2012
Primary Completion
July 1, 2016
Study Completion
October 1, 2016
Last Updated
August 31, 2018
Record last verified: 2018-08