Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Implantable Cardiac Monitor (Confirm ICM model 2102)
- Registration Number
- NCT01694394
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Implantable Cardiac Monitor (Confirm ICM model 2102) 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.
- Primary Outcome Measures
Name Time Method First atrial fibrillation episode at least 5 minutes in duration over maximum follow-up of 18 months incidence of atrial fibrillation detected by continuous monitoring by an implantable cardiac monitor
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Southlake Regional HealthCare
🇨🇦Newmarket, Ontario, Canada
Academisch Medisch Centrum (AMC) Amsterdam
🇳🇱Amsterdam, Netherlands
Diakonessenhuis Leiden
🇳🇱Leiden, Netherlands
Nij Smellinge
🇳🇱Drachten, Netherlands
Groene Hart Ziekenhuis Gouda
🇳🇱Gouda, Netherlands
Ikazia Hospital
🇳🇱Rotterdam, Netherlands
Hamilton Health Sciences - Interventional Cardiology
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Center University Hospital
🇨🇦London, Ontario, Canada
Queen Elizabeth-II Heather Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Hamilton Health Sciences - Electrophysiology Clinic
🇨🇦Hamilton, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hopital Laval)
🇨🇦Sainte-Foy, Quebec, Canada
St. Boniface Hospital
🇨🇦Winnepeg, Manitoba, Canada
Hamilton Health Sciences - Perioperative Ischemia Research Group
🇨🇦Hamilton, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Health Sciences North
🇨🇦Sudbury, Ontario, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Amphia Hospital
🇳🇱Breda, Netherlands