Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor

NCT ID: NCT01694394

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 256 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-10-31

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

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Implantable Cardiac Monitor (Confirm ICM model 2102)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

St. Jude Medical Confirm ICM model 2102

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

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeff Healey

Associate Professor, McMaster University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff Healey, M.D.

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Stuart Connolly, M.D.

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Marco Alings, M.D.

Role: PRINCIPAL_INVESTIGATOR

Working group Cardiovascular research Netherlands

Locations

University of Calgary

Calgary, Alberta, Canada

St. Boniface Hospital

Winnepeg, Manitoba, Canada

Queen Elizabeth-II Heather Sciences Center

Halifax, Nova Scotia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Hamilton Health Sciences - Electrophysiology Clinic

Hamilton, Ontario, Canada

Hamilton Health Sciences - Interventional Cardiology

Hamilton, Ontario, Canada

Hamilton Health Sciences - Perioperative Ischemia Research Group

Hamilton, Ontario, Canada

London Health Sciences Center University Hospital

London, Ontario, Canada

Southlake Regional HealthCare

Newmarket, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hopital Laval)

Sainte-Foy, Quebec, Canada

Academisch Medisch Centrum (AMC) Amsterdam

Amsterdam, , Netherlands

Amphia Hospital

Breda, , Netherlands

Nij Smellinge

Drachten, , Netherlands

Groene Hart Ziekenhuis Gouda

Gouda, , Netherlands

Diakonessenhuis Leiden

Leiden, , Netherlands

Ikazia Hospital

Rotterdam, , Netherlands

Countries

Canada; Netherlands

References

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.

Reference Type: DERIVED

PMID: 28778946 (View on PubMed)

Other Identifiers

ASSERT-II

Identifier Type: -

Identifier Source: org_study_id