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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41317
Enrollment
150
Registered
2012-12-27
Start date
2013-03-28
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation palpitations

Interventions

None listed

Sponsors

Population Health Research Institute of Hamilton Health Sciences
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 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

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)

Design outcomes

Primary

MeasureTime frame
Number of patients with AF episodes longer than 5 minutes.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)