NCT02793895: SEARCH-AF

Detection of Atrial Fibrillation After Cardiac Surgery

Terminated NA Last updated 18 June 2021

What this trial tests

NA trial testing Medtronic SEEQ™ mobile cardiac telemetry system in Atrial Fibrillation in 336 participants. Terminated before completion.

Timeline

24 February 2017

Primary endpoint
31 August 2020

11 September 2020

Quick facts

Lead sponsor	Unity Health Toronto
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	336
Start date	24 February 2017
Primary completion	31 August 2020
Estimated completion	11 September 2020
Sites	10 locations across Canada

Drugs / interventions tested

• Medtronic SEEQ™ mobile cardiac telemetry system
• Usual Care
• CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Atrial Flutter — all drugs for Atrial Flutter →
• C.Surgical Procedure; Cardiac — all drugs for C.Surgical Procedure; Cardiac →
• Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Continuous Electrocardiogram Monitoring on Detection of Undiagnosed Atrial Fibrillation After Hospitalization for Cardiac Surgery: A Randomized Clinical Trial.
   Ha ACT, Verma S, Mazer CD, Quan A, et al · · 2021 · cited 44× · PMID 34448866 · DOI 10.1001/jamanetworkopen.2021.21867
2. Remote Cardiac Rhythm Monitoring in the Era of Smart Wearables: Present Assets and Future Perspectives.
   Xintarakou A, Sousonis V, Asvestas D, Vardas PE, et al · · 2022 · cited 31× · PMID 35299975 · DOI 10.3389/fcvm.2022.853614
3. The Impact of Statins on Postdischarge Atrial Fibrillation After Cardiac Surgery: Secondary Analysis from a Randomized Trial.
   Hibino M, Verma S, Pandey AK, Bisleri G, et al · · 2023 · cited 1× · PMID 37124963 · DOI 10.1016/j.cjco.2022.12.012