Atrial FibrillationSEARCH-AFNCT02793895
Detection of Atrial Fibrillation After Cardiac Surgery
A study testing Medtronic SEEQ™ mobile cardiac telemetry system and CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device in people with Atrial Fibrillation and Atrial Flutter, run by Unity Health Toronto at 10 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, C.Surgical Procedure; Cardiac
- What is being tested?
- Medtronic SEEQ™ mobile cardiac telemetry system and CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 10 sitesCanada
- Study dates
- 24 Feb 2017to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥18 years.
- Isolated CABG or valve replacement/repair +/- CABG performed at the index surgical procedure.
- At elevated risk of stroke and for having POAF/AFL, defined as having a 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 of ≥4 or ≥2 with at least 1 of the following risk factors for developing POAF/AFL:
- Chronic obstructive pulmonary disease; (ii) Sleep apnea; (iii) Impaired renal function (defined as creatinine clearance <60 ml/min/1.73m2 or <60 ml/min); (iv) Echocardiographic evidence of at least mild left atrial enlargement (defined as ≥41 mm on M-mode, ≥59 ml or ≥29 mL/m2 on biplane volume assessment from an echocardiogram performed within 12 months of study enrollment); (v) Elevated body mass index (defined as BMI ≥30); (vi) Combined surgery (CABG + valve repair/replacement).
- Able to provide written informed consent.
Who cannot join
- Atrial fibrillation or flutter at the time of randomization.
- Known previous history of AF/AFL, diagnosed pre-operatively (note: documentation of a history of AF/AFL without accompanying rhythm proof will suffice).
- Documentation of continuous AF/AFL for ≥24 hours during the in-hospital stay for the index cardiac surgery.
- Subjects who, at the discretion of the treating cardiac surgery team, would be treated and discharged with oral anticoagulation due to POAF/AFL.
- Mechanical valve replacement.
- Current or anticipated treatment with oral anticoagulation for indications other than AF/AFL.
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- Hospitalization for ≥10 days (for the index cardiac surgery, with day #0 being the day of surgery).
- Planned discharge from hospital with a type IC or III anti-arrhythmic drug.
- Having received >5 grams of IV and/or oral amiodarone during hospitalization for the index cardiac surgical procedure.
- Women of childbearing potential (WOCBP).
- History of percutaneous or surgical left atrial ablation for AF.
- Presence of a cardiac implantable electronic device with a functioning atrial lead (pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization device).
- Presence of an implantable loop recorder.
- History of left atrial appendage ligation, removal, or occlusion.
- Subjects with known allergies or hypersensitivities to adhesives or hydrogel.
- Inability to provide written informed consent.
- Current or anticipated participation in another randomized controlled trial in which the interventional drug or device is known to affect the incidence of the primary or secondary outcomes of this study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Foothills Medical Centre
Calgary, T2N 4N1
Mazankowski Alberta Heart Institute
Edmonton, T6G 2B7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 3S9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4E9
Université Laval
Québec, Quebec, G1V 4G2
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
St. Michael's Hospital
Toronto, Ontario, M5B1W8
University Health Network
Toronto, Ontario, M5G 2C4
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Post-Surgical Enhanced Monitoring for Cardiac Arrhythmias and Atrial Fibrillation (SEARCH-AF): A Randomized Controlled Trial
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.
Read the 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 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.
- Being tested
- Medtronic SEEQ™ mobile cardiac telemetry system, Usual Care, CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device
- Keywords
- Atrial fibrillation/flutter, Postoperative atrial arrhythmia, Cardiac surgery, Stroke prevention, Oral anticoagulation, Cardiac rhythm monitoring
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic SEEQ™ mobile cardiac telemetry systemDevice
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.
Usual CareOther
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 or the CardioSTAT (Icentia. Inc) cardiac rhythm monitoring device.
CardioSTAT (Icentia Inc.) cardiac rhythm monitoring deviceDevice
The CardioSTAT device is a wearable adhesive cardiac rhythm monitoring system which is low-profile, water-resistant, and is adhered onto the skin surface with 2 electrodes. This wearable adhesive device is designed for one-time use only. Each CardioSTAT device will provide 14 days of cardiac rhythm monitoring. For subjects randomized to the intervention group who will be monitored by the CardioSTAT device, they will receive 28 days of continuous cardiac rhythm monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced cardiac rhythm monitoring | Experimental | Subjects in this group will receive up to 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 or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. At 6+/-1 months, subjects randomized to the intervention group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. Receives: Device: Medtronic SEEQ™ mobile cardiac telemetry system; Device: CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device |
| Usual care | Active comparator | 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 or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The primary endpoint of this trial is documentation of sustained AF/AFL, defined as a cumulative AF/AFL duration 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 clinical events committee.
Measured: Within 30 days of randomization.
Secondary outcomes (10)
Number of participants with atrial fibrillation or flutter lasting for ≥24 hours.
This outcome will be measured by a continuous cardiac modality (e.g. Holter, Event monitor, SEEQ™ mobile cardiac telemetry system, CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device).
Measured: (i) Within 30 days of randomization and (ii) Between day 31 and the last follow-up date.
Duration of cumulative atrial fibrillation or flutter burden amongst participants.
This outcome will be measured by a continuous cardiac modality (e.g. Holter, Event monitor, SEEQ™ mobile cardiac telemetry system, CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device).
Measured: Between day 31 of randomization and the last follow-up date.
Number of participants who are prescribed with oral anticoagulation for atrial fibrillation or flutter-related stroke prevention.
This outcome will be collected during study follow-up visits.
Measured: (i) Within the first 45 days after discharge from cardiac surgery; (ii) Between day 46 and the last follow-up date.
Number of days during which the adhesive Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device was worn by participants.
This outcome will be collected during study follow-up visits.
Measured: (i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).
Number of participants who prematurely remove the adhesive Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device.
This outcome will be collected during study follow-up visits.
Measured: (i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).
Number of participants with adverse events related to the use of the Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device.
This outcome will be collected during study follow-up visits.
Measured: (i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).
Number of participants who undergo non-protocol mandated Holter monitoring and/or event recorders.
This outcome will be collected during study follow-up visits.
Measured: (i) Within 30 days after randomization; (ii) Between day 31 and the last follow-up date.
Hospitalization or emergency room visits.
This outcome will be collected during study follow-up visits.
Measured: Within the first 45 days after hospital discharge from index cardiac surgery.
Major adverse cardiac outcomes.
All-cause death, myocardial infarction, ischemic stroke, non-CNS systemic embolism.
Measured: (i) Within the first 45 days after hospital discharge from index cardiac surgery; (ii) Between day 46 and the last follow-up date.
Number of participants with bleeding events.
Major bleeding.
Measured: (i) Within the first 45 days after hospital discharge from index cardiac surgery; (ii) Between day 46 and the last follow-up date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start24 Feb 2017
- Primary completion31 Aug 2020
- Study completion11 Sep 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew CT Ha, MD, Principal investigator, University Health Network, TorontoAtul Verma, MD, Principal investigator, St. Michael's Hospital and Southlake Regional Health CentreSubodh Verma, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793895
- Sponsor's protocol ID
- SEARCH-AF-001
- Acronym
- SEARCH-AF
- Status last verified
- Jun 2021
- First submitted
- 2 May 2016
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ha ACT, Verma S, Mazer CD, Quan A, Yanagawa B, Latter DA, Yau TM, Jacques F, Brown CD, Singal RK, Yamashita MH, Saha T, Teoh KH, Lam BK, Deyell MW, Wilson M, Hibino M, Cheung CC, Kosmopoulos A, Garg V, Brodutch S, Teoh H, Zuo F, Thorpe KE, Juni P, Bhatt DL, Verma A; SEARCH AF CardioLink-1 Investigators. Effect of Continuous Electrocardiogram Monitoring on Detection of Undiagnosed Atrial Fibrillation After Hospitalization for Cardiac Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121867. doi: 10.1001/jamanetworkopen.2021.21867.
PubMed 34448866Yanagawa B, Ad N, Gaudino MF. Commentary: Postoperative atrial fibrillation can last years? Oh snap! J Thorac Cardiovasc Surg. 2020 Apr;159(4):1417-1418. doi: 10.1016/j.jtcvs.2019.04.028. Epub 2019 Apr 24. No abstract available.
PubMed 31155412
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Surgical Enhanced Monitoring for Cardiac Arrhythmias and Atrial Fibrillation (SEARCH-AF): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02793895
- Acronym / sponsor ID
- SEARCH-AF / SEARCH-AF-001
- Keywords
- Atrial fibrillation/flutter, Postoperative atrial arrhythmia, Cardiac surgery, Stroke prevention, Oral anticoagulation, Cardiac rhythm monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced cardiac rhythm monitoring | Experimental | Device: Medtronic SEEQ™ mobile cardiac telemetry system, Device: CardioSTAT (Icentia Inc.) cardiac rhythm monitoring deviceSubjects in this group will receive up to 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 or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. At 6+/-1 months, subjects randomized to the intervention group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. |
| Usual care | Active comparator | Other: Usual CareSubjects 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 or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age ≥18 years.
- Isolated CABG or valve replacement/repair +/- CABG performed at the index surgical procedure.
- At elevated risk of stroke and for having POAF/AFL, defined as having a 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 of ≥4 or ≥2 with at least 1 of the following risk factors for developing POAF/AFL:
- Able to provide written informed consent.
Key exclusion criteria (17 listed)
- Atrial fibrillation or flutter at the time of randomization.
- Known previous history of AF/AFL, diagnosed pre-operatively (note: documentation of a history of AF/AFL without accompanying rhythm proof will suffice).
- Documentation of continuous AF/AFL for ≥24 hours during the in-hospital stay for the index cardiac surgery.
- Subjects who, at the discretion of the treating cardiac surgery team, would be treated and discharged with oral anticoagulation due to POAF/AFL.
- Mechanical valve replacement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic SEEQ™ mobile cardiac telemetry systemThe 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. | Device | Enhanced cardiac rhythm monitoring |
| Usual CareFor 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 or the CardioSTAT (Icentia. Inc) cardiac rhythm monitoring device. | Other | Usual care |
| CardioSTAT (Icentia Inc.) cardiac rhythm monitoring deviceThe CardioSTAT device is a wearable adhesive cardiac rhythm monitoring system which is low-profile, water-resistant, and is adhered onto the skin surface with 2 electrodes. This wearable adhesive device is designed for one-time use only. Each CardioSTAT device will provide 14 days of cardiac rhythm monitoring. For subjects randomized to the intervention group who will be monitored by the CardioSTAT device, they will receive 28 days of continuous cardiac rhythm monitoring. | Device | Enhanced cardiac rhythm monitoring |
Primary outcome
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
Time frame: Within 30 days of randomization.
The primary endpoint of this trial is documentation of sustained AF/AFL, defined as a cumulative AF/AFL duration 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 clinical events committee.
10 secondary outcomes
Number of participants with atrial fibrillation or flutter lasting for ≥24 hours.
Time frame: (i) Within 30 days of randomization and (ii) Between day 31 and the last follow-up date.
Duration of cumulative atrial fibrillation or flutter burden amongst participants.
Time frame: Between day 31 of randomization and the last follow-up date.
Number of participants who are prescribed with oral anticoagulation for atrial fibrillation or flutter-related stroke prevention.
Time frame: (i) Within the first 45 days after discharge from cardiac surgery; (ii) Between day 46 and the last follow-up date.
Number of days during which the adhesive Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device was worn by participants.
Time frame: (i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).
Number of participants who prematurely remove the adhesive Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device.
Time frame: (i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).
Number of participants with adverse events related to the use of the Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device.
Time frame: (i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).
Number of participants who undergo non-protocol mandated Holter monitoring and/or event recorders.
Time frame: (i) Within 30 days after randomization; (ii) Between day 31 and the last follow-up date.
Hospitalization or emergency room visits.
Time frame: Within the first 45 days after hospital discharge from index cardiac surgery.
Major adverse cardiac outcomes.
Time frame: (i) Within the first 45 days after hospital discharge from index cardiac surgery; (ii) Between day 46 and the last follow-up date.
Number of participants with bleeding events.
Time frame: (i) Within the first 45 days after hospital discharge from index cardiac surgery; (ii) Between day 46 and the last follow-up date.
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 34448866Ha ACT, Verma S, Mazer CD, Quan A, Yanagawa B, Latter DA, Yau TM, Jacques F, Brown CD, Singal RK, Yamashita MH, Saha T, Teoh KH, Lam BK, Deyell MW, Wilson M, Hibino M, Cheung CC, Kosmopoulos A, Garg V, Brodutch S, Teoh H, Zuo F, Thorpe KE, Juni P, Bhatt DL, Verma A; SEARCH AF CardioLink-1 Investigators. Effect of Continuous Electrocardiogram Monitoring on Detection of Undiagnosed Atrial Fibrillation After Hospitalization for Cardiac Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121867. doi: 10.1001/jamanetworkopen.2021.21867.
- Derived from this study: PubMed 31155412Yanagawa B, Ad N, Gaudino MF. Commentary: Postoperative atrial fibrillation can last years? Oh snap! J Thorac Cardiovasc Surg. 2020 Apr;159(4):1417-1418. doi: 10.1016/j.jtcvs.2019.04.028. Epub 2019 Apr 24. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew CT Ha, MD principal investigator
University Health Network, Toronto
Atul Verma, MD principal investigator
St. Michael's Hospital and Southlake Regional Health Centre
Subodh Verma, MD, PhD principal investigator
Unity Health Toronto
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic SEEQ™ mobile cardiac telemetry system and CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device in people with Atrial Fibrillation and Atrial Flutter, run by Unity Health Toronto at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 30 days of randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.