Detection of Atrial Fibrillation After Cardiac Surgery

NCT02793895 | Terminated

• 1 other identifier: SEARCH-AF-001
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 days of randomization.

Secondary Outcomes (10)

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

  (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.

  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.

  (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.

  (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.

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

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Medtronic SEEQ™ mobile cardiac telemetry system DEVICE

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.

Enhanced cardiac rhythm monitoring

Usual Care OTHER

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.

Usual care

CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device DEVICE

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.

Enhanced cardiac rhythm monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (10)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 3S9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Foothills Medical Centre

Calgary, T2N 4N1, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, T6G 2B7, Canada

Location

Related Publications (2)

• 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.

  PMID: 34448866 DERIVED

• 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.

  PMID: 31155412 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew CT Ha, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Atul Verma, MD

  St. Michael's Hospital and Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

• Subodh Verma, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: June 8, 2016
• Study Start: February 24, 2017
• Primary Completion: August 31, 2020
• Study Completion: September 11, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)