Clinical Trials Logo

Clinical Trial Summary

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 ≥75 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 up to 30 days of continuous cardiac rhythm monitoring with an adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device). 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 SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device at 6±1 months after their index cardiac surgery.


Clinical Trial Description

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. Its primary objective is to test whether enhanced cardiac rhythm monitoring with an adhesive, continuous monitor results in higher rates of atrial fibrillation or flutter (AF/AFL) detection at 30 days after randomization for post-cardiac surgical subjects who are at risk for developing post-operative atrial arrhythmias, when compared to usual care. The study design is an open-label, two-arm randomized controlled trial (RCT) comparing a strategy of enhanced cardiac rhythm monitoring vs. usual care in 396 post-cardiac surgical subjects who are at risk for developing POAF/AFL. The primary endpoint is the proportion of subjects with a cumulative AF/AFL burden of ≥6 minutes or documentation of AF/AFL by a 12-lead ECG within 30 days after randomization. Clinical endpoints will be adjudicated by an independent committee of physicians. The study population involves post-cardiac surgical subjects at high risk of stroke, defined as having a CHA2DS2-VASC score of ≥4 or CHA2DS2-VASC of ≥2 with additional risk factors for developing POAF/AFL. These subjects must not have a history of AF/AFL pre-operatively. Subjects who meet inclusion criteria will be randomized in a 1:1 ratio to one of the following 2 arms: (i) Enhanced cardiac rhythm monitoring (intervention group) or (ii) Usual care (control group). Subjects in the intervention group will receive up to 30 days of continuous cardiac rhythm monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. Monitoring will begin on the day of randomization. Subjects in the usual care group will not undergo protocol-mandated cardiac rhythm monitoring during the first 30 days after randomization. All subjects will have a follow-up visit at 31-90 days after hospital discharge and at 6±1 months after surgery. At 6±1 months, all subjects will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. A telephone follow-up will be performed for all subjects at 9±1 months after surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02793895
Study type Interventional
Source Unity Health Toronto
Contact
Status Terminated
Phase N/A
Start date February 24, 2017
Completion date September 11, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A