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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
Sponsor:
Collaborators:
Abbott Medical Devices
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jeff Healey, Population Health Research Institute

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
Atrial Fibrillation Device: Implantable Cardiac Monitor (Confirm ICM model 2102)

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Detailed Description:

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.

Study Objectives

Primary Objectives:

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.

Secondary Objectives

  1. 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.
  2. To determine the relationship between left atrial volume (continuous variable) and the risk of sub-clinical AF.
  3. 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.
  4. 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


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Study Type : Observational
Actual Enrollment : 256 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
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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
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)


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


Locations
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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
Abbott Medical Devices
Canadian Institutes of Health Research (CIHR)
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes