NL-OMON41317
Completed
Not Applicable
Presence of Sub-Clinical Atrial Fibrillation using an implantable cardiac monitor in patients with cardiovascular risk factors (ASSERT II) - ASSERT II
Population Health Research Institute of Hamilton Health Sciences0 sites150 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- atrial fibrillation
- Sponsor
- Population Health Research Institute of Hamilton Health Sciences
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •b. Obstructive sleep apnea (documented by polysomnography, ambulatory oximetry, positive Berlin Questionnaire or requiring the use of CPAP/BiPAP)
- •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)
- •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)
Outcomes
Primary Outcomes
Not specified
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