Detection of Atrial Fibrillation After Cardiac Surgery "SEARCH-AF"

Recruiting

Phase N/A Results N/A

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. 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 30 days of continuous cardiac rhythm monitoring with an adhesive, patch-based monitor (Medtronic SEEQ™ 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 SEEQ™ mobile cardiac telemetry system at 6±1 months after their index cardiac surgery.

Detailed 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 30 days of continuous cardiac rhythm monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system. 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 45-52 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. A telephone follow-up will be performed for all subjects at 9±1 months after surgery.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: 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 SEEQ™ device.
    ARM 1: Kind: Experimental
    Label: Usual care
    Description: Subjects randomized to the usual care arm will be discharged from hospital without protocol-mandated continuous cardiac rhythm monitoring. Within the first 30 days after randomization, no protocol-mandated cardiac rhythm assessment will be arranged. At 6+/-1 months, subjects randomized to the usual care group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device.
  • Medtronic SEEQ™ mobile cardiac telemetry system Device
    Intervention Desc: The SEEQ™ 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 SEEQ™ device at the time of randomization. At 6+/-1 months, subjects randomized to the intervention group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device.
    ARM 1: Kind: Experimental
    Label: Enhanced cardiac rhythm monitoring
    Description: Subjects in this group will receive 30 days of continuous cardiac rhythm monitoring with an adhesive monitor. Cardiac rhythm monitoring will begin on the day of randomization. The device that will be used is the Medtronic SEEQ™ mobile cardiac telemetry system. At 6+/-1 months, subjects randomized to the intervention group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with a cumulative atrial fibrillation/flutter (AF/AFL) duration of ≥6 minutes or documentation of AF/AFL by a 12-lead electrocardiogram Within 30 days of randomization No
Secondary Number of participants with atrial fibrillation or flutter lasting for ≥24 hours (i) Within 30 days of randomization and (ii) At 6±1 months after surgery No
Secondary Duration of cumulative atrial fibrillation or flutter burden amongst participants During the 14-day cardiac rhythm monitoring period at 6±1 months after surgery No
Secondary Number of participants who are prescribed with oral anticoagulation for atrial fibrillation or flutter-related stroke prevention (i) 45 days after discharge from cardiac surgery; (ii) 6±1 months after surgery; (iii) 9±1 months after cardiac surgery. No
Secondary Number of days during which the adhesive Medtronic SEEQ™ sensor was worn by participants (i) Within 30 days after randomization (intervention group only); (ii) 6±1 months after surgery (all subjects). No
Secondary Number of participants who prematurely remove the adhesive Medtronic SEEQ™ sensor. (i) Within 30 days after randomization (intervention group only); (ii) 6±1 months after surgery (all subjects). No
Secondary Number of participants with adverse events related to the use of the Medtronic SEEQ™ device. (i) Within 30 days after randomization (intervention group only); (ii) 6±1 months after surgery (all subjects). Yes
Secondary Number of participants who undergo non-protocol mandated Holter monitoring and/or event recorders. Within 30 days after randomization (all subjects). No
Secondary Hospitalization or emergency room visits. Within the first 45 days after hospital discharge from index cardiac surgery. No
Secondary Major adverse cardiac outcomes. Within the first 45 days after hospital discharge from index cardiac surgery. Yes
Secondary Number of participants with bleeding events. Within the first 45 days after hospital discharge from index cardiac surgery. Yes

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