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

Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patient With Cardiovascular Risk Factors (ASSERT-II)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Implantable Cardiac Monitor (Confirm ICM model 2102)

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
• Enrollment (Actual): 256

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary
  • Manitoba
    • Winnepeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth-II Heather Sciences Center
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • 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
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Center University Hospital
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional HealthCare
    • Ottawa, Ontario, Canada, 613-761-5208
      • University of Ottawa Heart Institute
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H9S 1H4
      • McGill University Health Centre
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
• Netherlands
  • Amsterdam, Netherlands, 1100 DD
    • Academisch Medisch Centrum (AMC) Amsterdam
  • Breda, Netherlands, 4818 CK
    • Amphia Hospital
  • Drachten, Netherlands, 9202 DA
    • Nij Smellinge
  • Gouda, Netherlands, 2803 HH
    • Groene Hart Ziekenhuis Gouda
  • Leiden, Netherlands, 2334 CK
    • Diakonessenhuis Leiden
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: St. Jude Medical Confirm ICM model 2102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Abbott Medical Devices
• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 23, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: atrial fibrillation; cardiovascular risk; implantable cardiac monitor; left atrial enlargement; CHA2DS2 VASc Score
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ASSERT-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided