Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II)
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|ClinicalTrials.gov Identifier: NCT01694394|
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Device: Implantable Cardiac Monitor (Confirm ICM model 2102)|
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Title of Study Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patients with Cardiovascular Risk Factors (ASSERT-II) Short Title ASSERT-II Study Sponsor Population Health Research Institute (Grant in Aid from St. Jude Medical, Inc.) Principal Investigators Dr. J. Healey, Dr. S. Connolly, Dr. M. Alings Central Coordinating Centre Population Health Research Institute Recruitment and Participating Clinical Sites 250 patients from approximately 30 Sites Phase/Regulatory Status Phase IV - Cohort Study Hypothesis Among elderly patients with cardiovascular risk factors and a left atrial diameter ≥ 4.4 cm, but without prior clinical AF, an implanted continuous ECG monitor (St. Jude Medical Confirm® Implantable Cardiac Monitor) will detect subclinical AF (≥ 5 minutes in duration) in 12% or more of patients during an average follow-up of 12 months.
1. To determine the rate of detection of sub-clinical atrial AF (≥ 5 minutes) within an average of 12 months following implant of the St. Jude Medical Confirm® Implantable Cardiac Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF.
- To determine if the incidence of sub-clinical AF is higher among patients whose left atrial volume is above the median value observed in this study.
- To determine the relationship between left atrial volume (continuous variable) and the risk of sub-clinical AF.
- To evaluate other potential predictors of sub-acute AF in this population including: baseline troponin-T, baseline NT-pro-BNP as well as clinical and other echocardiographic parameters.
- To develop a preliminary economic analysis to evaluate the potential cost-effectiveness of screening this patient population with an Implantable Cardiac Monitor as a means of preventing stroke.
Study Design Cohort study to determine the prevalence of sub-clinical AF in an elderly population with common cardiovascular risk factors, such as hypertension and diabetes. Patients with echocardiographic evidence of atrial enlargement will be enrolled and have the St. Jude Medical Confirm® Implantable Cardiac Monitor (Confirm® ICM) subcutaneously implanted. To reduce costs, in most cases the implant will be done in conjunction with other planned surgery or heart catheterization.
PHRI: CONFIDENTIAL Final Version 2.0:2012-06-18 Page 4 of 24 Participants/Study Duration Total of 250 participants will be enrolled over 16 months. The last patient enrolled will have 9 months of follow-up, for a total study duration of approximately 25 months. Clinic visits will occur at enrolment and months 3, 6 and 9. A final visit will take place at 18 months of follow-up, or after the last patient enrolled has been followed for 9 months (whichever comes first).
Study Population Patients with known cardiovascular risk factors and left atrial enlargement, with no prior documented AF.
Intervention St. Jude Medical Confirm® Implantable Cardiac Monitor (Confirm® ICM) Enrollment and Follow-up Eligible and consenting patients will be enrolled and have the Confirm® ICM implanted. The implant may take place in conjunction with pre-planned non-cardiac surgery, heart catheterization, or as a stand-alone procedure. Follow-up visits will occur at month 3, 6 and 9. A final visit will take place at 18 months of follow-up, or after the last patient enrolled has been followed for 9 months (whichever comes first).
Assessment of Outcome Events An independent central adjudication committee comprised of arrhythmia experts will evaluate device-detected AF episodes.
Statistical Methodology Determine the incidence of sub-clinical atrial AF (≥ 5 minutes) using the Confirm® ICM.
Date of Protocol June 18, 2012
|Study Type :||Observational|
|Actual Enrollment :||256 participants|
|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|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||October 2016|
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.
Device: Implantable Cardiac Monitor (Confirm ICM model 2102)
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.
Other Name: St. Jude Medical Confirm ICM model 2102
- 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
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
|University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|St. Boniface Hospital|
|Winnepeg, Manitoba, Canada, R2H 2A6|
|Canada, Nova Scotia|
|Queen Elizabeth-II Heather Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|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|
|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|
|Breda, Netherlands, 4818 CK|
|Drachten, Netherlands, 9202 DA|
|Groene Hart Ziekenhuis Gouda|
|Gouda, Netherlands, 2803 HH|
|Leiden, Netherlands, 2334 CK|
|Rotterdam, Netherlands, 3083 AN|
|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|