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

• ClinicalTrials.gov Identifier: NCT01694394
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Last Update Posted: August 31, 2018
• Sponsor: Population Health Research Institute
• Collaborators: Abbott Medical Devices; Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Jeff Healey, Population Health Research Institute

Study Description

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)

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 Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jeff Healey, Associate Professor, McMaster University, Population Health Research Institute
• ClinicalTrials.gov Identifier: NCT01694394
• Other Study ID Numbers: ASSERT-II
• First Posted: September 27, 2012
• 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:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes