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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

Tracking Information
First Submitted Date September 23, 2012
First Posted Date September 27, 2012
Last Update Posted Date August 31, 2018
Study Start Date December 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2012)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01694394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor
Official Title Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patient With Cardiovascular Risk Factors (ASSERT-II)
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.
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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood will be collected for NT-ProBNP and hs-Troponin-T
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
Condition Atrial Fibrillation
Intervention 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
Study Groups/Cohorts 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.
Intervention: Device: Implantable Cardiac Monitor (Confirm ICM model 2102)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 28, 2018)
256
Original Estimated Enrollment
 (submitted: September 26, 2012)
250
Actual Study Completion Date October 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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)

Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01694394
Other Study ID Numbers ASSERT-II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jeff Healey, Population Health Research Institute
Study Sponsor Population Health Research Institute
Collaborators
  • Abbott Medical Devices
  • 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
PRS Account Population Health Research Institute
Verification Date August 2018