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Detection of Atrial Fibrillation After Cardiac Surgery (SEARCH-AF)

Primary Purpose

Atrial Fibrillation, Atrial Flutter, C.Surgical Procedure; Cardiac

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Medtronic SEEQ™ mobile cardiac telemetry system

Usual Care

CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial fibrillation/flutter, Postoperative atrial arrhythmia, Cardiac surgery, Stroke prevention, Oral anticoagulation, Cardiac rhythm monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
(i) 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.

Exclusion Criteria:

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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced cardiac rhythm monitoring

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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).

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.

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.

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.

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.

Number of participants who undergo non-protocol mandated Holter monitoring and/or event recorders.

This outcome will be collected during study follow-up visits.

Hospitalization or emergency room visits.

This outcome will be collected during study follow-up visits.

Major adverse cardiac outcomes.

All-cause death, myocardial infarction, ischemic stroke, non-CNS systemic embolism.

Number of participants with bleeding events.

Major bleeding.

Full Information

NCT ID

NCT02793895

First Posted

May 2, 2016

Last Updated

June 14, 2021

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02793895

Brief Title

Detection of Atrial Fibrillation After Cardiac Surgery

Acronym

SEARCH-AF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 pandemic

Study Start Date

February 24, 2017 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

September 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Atrial Flutter, C.Surgical Procedure; Cardiac, Arrhythmias, Cardiac

Keywords

Atrial fibrillation/flutter, Postoperative atrial arrhythmia, Cardiac surgery, Stroke prevention, Oral anticoagulation, Cardiac rhythm monitoring

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

336 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enhanced cardiac rhythm monitoring

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Medtronic SEEQ™ mobile cardiac telemetry system

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual Care

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Within 30 days of randomization.

Secondary Outcome Measure Information:

Title

Number of participants with atrial fibrillation or flutter lasting for ≥24 hours.

Description

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).

Time Frame

(i) Within 30 days of randomization and (ii) Between day 31 and the last follow-up date.

Title

Duration of cumulative atrial fibrillation or flutter burden amongst participants.

Description

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).

Time Frame

Between day 31 of randomization and the last follow-up date.

Title

Number of participants who are prescribed with oral anticoagulation for atrial fibrillation or flutter-related stroke prevention.

Description

This outcome will be collected during study follow-up visits.

Time Frame

(i) Within the first 45 days after discharge from cardiac surgery; (ii) Between day 46 and the last follow-up date.

Title

Number of days during which the adhesive Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device was worn by participants.

Description

This outcome will be collected during study follow-up visits.

Time Frame

(i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).

Title

Number of participants who prematurely remove the adhesive Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device.

Description

This outcome will be collected during study follow-up visits.

Time Frame

(i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).

Title

Number of participants with adverse events related to the use of the Medtronic SEEQ™ or CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device.

Description

This outcome will be collected during study follow-up visits.

Time Frame

(i) Within 30 days after randomization (intervention group only); (ii) Between day 31 and the last follow-up date (all subjects).

Title

Number of participants who undergo non-protocol mandated Holter monitoring and/or event recorders.

Description

This outcome will be collected during study follow-up visits.

Time Frame

(i) Within 30 days after randomization; (ii) Between day 31 and the last follow-up date.

Title

Hospitalization or emergency room visits.

Description

This outcome will be collected during study follow-up visits.

Time Frame

Within the first 45 days after hospital discharge from index cardiac surgery.

Title

Major adverse cardiac outcomes.

Description

All-cause death, myocardial infarction, ischemic stroke, non-CNS systemic embolism.

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.

Title

Number of participants with bleeding events.

Description

Major bleeding.

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: (i) 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew CT Ha, MD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Atul Verma, MD

Organizational Affiliation

St. Michael's Hospital and Southlake Regional Health Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Subodh Verma, MD, PhD

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Boniface General Hospital

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

Saint John Regional Hospital

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Kingston General Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Southlake Regional Health Centre

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3S9

Country

Canada

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B1W8

Country

Canada

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Université Laval

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Foothills Medical Centre

City

Calgary

ZIP/Postal Code

T2N 4N1

Country

Canada

Facility Name

Mazankowski Alberta Heart Institute

City

Edmonton

ZIP/Postal Code

T6G 2B7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34448866

Citation

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.

Results Reference

derived

PubMed Identifier

31155412

Citation

Yanagawa 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.

Results Reference

derived

Learn more about this trial

Detection of Atrial Fibrillation After Cardiac Surgery

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Detection of Atrial Fibrillation After Cardiac Surgery (SEARCH-AF)

Atrial Fibrillation, Atrial Flutter, C.Surgical Procedure; Cardiac

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial