Clinical trial · Observational
Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery
NCT04325269CI-TRIAL-00044441unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Atrial fibrillation (AF) is a common and serious complication after lung resection. The incidence is likely underestimated, and risk may persist after leaving hospital. Recent development of simple wearable patch ECG devices may provide sensitive detection of AF in the extended postoperative period. Specific biomarkers may allow us to predict which patients are at risk of developing postoperative AF.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Absolute incidence of postoperative atrial fibrillation
- timeFrame
- 14 days postop
- description
- Detected by device
Secondary outcomes (9)
- measure
- Rate of accrual relative to the number of eligible patients per month
- timeFrame
- 6-month recruitment period
- description
- Determined by proportion of patients enrolled
- measure
- 90-day mortality
- timeFrame
- 90 days following surgery
- description
- Determined by telephone follow-up and check of medical records
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients, age ≥ 55 years at time of surgery, undergoing thoracic surgery with general anesthesia 2. Co-enrolment in the NT-proBNP biomarker monitoring study Exclusion Criteria: 1. Patients with a prior history of documented AF 2. Patients with an implanted pacemaker or defibrillator 3. Patients currently taking anti-arrhythmic medication other than ß- blockers, calcium channel blockers or digoxin 4. Patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies) 5. Patients who are unable or unwilling to wear the CardioSTAT device as per manufacturer's guidelines, or who are unable/unwilling to return the device via mail to Icentia for procession and analysis 6. Patients with known allergy to adhesives
References
Publications (4)
- BACKGROUNDHealey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575. PMID 22236222
- BACKGROUNDVascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Spence J, LeManach Y, Chan MTV, Wang CY, Sigamani A, Xavier D, Pearse R, Alonso-Coello P, Garutti I, Srinathan SK, Duceppe E, Walsh M, Borges FK, Malaga G, Abraham V, Faruqui A, Berwanger O, Biccard BM, Villar JC, Sessler DI, Kurz A, Chow CK, Polanczyk CA, Szczeklik W, Ackland G, X GA, Jacka M, Guyatt GH, Sapsford RJ, Williams C, Cortes OL, Coriat P, Patel A, Tiboni M, Belley-Cote EP, Yang S, Heels-Ansdell D, McGillion M, Parlow S, Patel M, Pettit S, Yusuf S, Devereaux PJ. Association between complications and death within 30 days after noncardiac surgery. CMAJ. 2019 Jul 29;191(30):E830-E837. doi: 10.1503/cmaj.190221. PMID 31358597
- RESULTLowres N, Mulcahy G, Gallagher R, Ben Freedman S, Marshman D, Kirkness A, Orchard J, Neubeck L. Self-monitoring for atrial fibrillation recurrence in the discharge period post-cardiac surgery using an iPhone electrocardiogram. Eur J Cardiothorac Surg. 2016 Jul;50(1):44-51. doi: 10.1093/ejcts/ezv486. Epub 2016 Feb 4. PMID 26850266
- RESULTBidar E, Maesen B, Nieman F, Verheule S, Schotten U, Maessen JG. A prospective randomized controlled trial on the incidence and predictors of late-phase postoperative atrial fibrillation up to 30 days and the preventive value of biatrial pacing. Heart Rhythm. 2014 Jul;11(7):1156-62. doi: 10.1016/j.hrthm.2014.03.040. Epub 2014 Mar 21. PMID 24657803