Presence of Sub-Clinical Atrial Fibrillation using an implantable cardiac monitor in patients with cardiovascular risk factors (ASSERT II)

Completed

Conditions: atrial fibrillation
palpitations
10007521

Registration Number: NL-OMON41317

Lead Sponsor: Population Health Research Institute of Hamilton Health Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Patients will be eligible for inclusion if they provide written consent and meet both of the following:
1. Age * 65, plus:
a. CHA2DS2-VASc score * 2
Or
b. Obstructive sleep apnea (documented by polysomnography, ambulatory oximetry, positive Berlin Questionnaire or requiring the use of CPAP/BiPAP)
Or
c. BMI > 30;AND;2. Echocardiographic or biochemical evidence of increased risk of AF:
a. Left atrial enlargement on a clinical echocardiograph at any time prior to enrolment (defined as LA volume * 58 ml or LA diameter of * 4.4 cm)
Or
b. Serum NT-ProBNP * 290 pg/mL

Exclusion Criteria

1. Previously documented history of atrial fibrillation or atrial flutter, with an episode duration of at least 5 minutes
2. Current chronic treatment with oral anticoagulation (i.e., those on peri-operative prophylaxis would be eligible)
3. Patient with existing implanted pacemaker or defibrillator
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 & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of patients with AF episodes longer than 5 minutes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the relationship between left atrial volume (continuous variable)<br /><br>and the presence of AF.<br /><br>To evaluate potential predictors/markers of sub-acute AF including: troponin-T,<br /><br>NT-pro-BNP as well as echocardiographic parameters.<br /><br>A preliminary economic analysis of screening this patient population with an<br /><br>Implantable Cardiac Monitor.</p><br>