Clinical Trial

Detection of Atrial Fibrillation After Cardiac Surgery

Study Description

Detection of Atrial Fibrillation After Cardiac Surgery

The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during the early, sub-acute post-operative period. The population includes cardiac surgical subjects who have either developed or are at risk for developing new onset POAF/AFL and who are at risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure, hypertension, age a?Y75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA) (2 points), vascular disease, age 65-74 years, sex class (female)) score. These subjects must not have had a history of AF/AFL before cardiac surgery. The intervention group will undergo 30 days of continuous cardiac rhythm monitoring with an adhesive, patch-based monitor (Medtronic SEEQa"c mobile cardiac telemetry system). The control group will receive usual care, which does not involve planned cardiac rhythm testing within the first 30 days after study randomization. The primary outcome is documentation of sustained atrial fibrillation or flutter within the first 30 days after randomization. In addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm monitoring with the Medtronic SEEQa"c mobile cardiac telemetry system at 6A?1 months after their index cardiac surgery.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Device - Medtronic SEEQâ„¢ mobile cardiac telemetry system

The SEEQâ„¢ system consists of a wearable sensor which is a single-lead, low-profile, peel-and-stick device applied over the anterior left chest wall of the subject. The wearable patch is designed for one-time use only and cannot be re-applied if removed. Each sensor provides up to 7.5 days of monitoring. Subjects randomized to the intervention group will undergo 30 days of continuous cardiac rhythm monitoring with the SEEQâ„¢ device at the time of randomization. At 6+/-1 months, subjects random ...read more on ClinicalTrials.org

Usual Care

For subjects randomized to the usual care group, no protocol-mandated cardiac rhythm monitoring will be performed. However, subjects in the control group may undergo rhythm monitoring during the study period if their treating physicians deem that there is a clinical indication to so do. At 6+/-1 months, subjects randomized to the usual care group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQâ„¢ device.

Additional Information

Official Study Title

Post-Surgical Enhanced Monitoring for Cardiac Arrhythmias and Atrial Fibrillation (SEARCH-AF): A Randomized Controlled Trial

Clinical Trial ID

NCT02793895

ParticipAid ID

negDra