NCT06724718

Brief Summary

Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

December 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

December 5, 2024

Last Update Submit

June 11, 2025

Conditions

Postoperative Atrial FibrillationThoracic SurgerySmartwatchesRhythm MonitoringCardiovascular PrognosisAsymptomatic Atrial FibrillationRandomized Trial

Keywords

Postoperative atrial fibrillationthoracic surgerysmartwatchesrhythm monitoringcardiovascular prognosisasymptomatic atrial fibrillationrandomized trial

Outcome Measures

Primary Outcomes (1)

  • the incidence of POAF

    the incidence of POAF within seven days after scheduled thoracic surgery.

    at day 7

Secondary Outcomes (8)

  • Rate of asymptomatic POAF

    at day 7

  • Cardiovascular prognosis

    at day 3

  • Cardiovascular prognosis

    at 6 months

  • Feasibility of rhythm monitoring with a smartwatch

    at day 7

  • Recurrence of AF

    at 3 months

  • +3 more secondary outcomes

Study Arms (2)

Smartwatch group

EXPERIMENTAL

Experimental intervention using smartwatches for rhythm monitoring.

Other: smartwatchOther: ECG

Control group

ACTIVE COMPARATOR

Standard care without smartwatch monitoring

Other: ECG

Interventions

smartwatchOTHER

Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch

Smartwatch group
ECGOTHER

Detected POAF episodes will be confirmed via a 12-lead ECG

Control groupSmartwatch group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\>18 years old).
  • Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.
  • Scheduled pneumonectomy or lobectomy.
  • Admission to a conventional surgical unit postoperatively.
  • Ability to perform single-lead ECG using a smartwatch.
  • Coverage under a social security system.
  • Signed informed consent

You may not qualify if:

  • History of atrial fibrillation.
  • Requirement for telemetry for AV block or tachyarrhythmias (\>140 bpm).
  • Dependency on a pacemaker.
  • Participation in another interventional clinical trial affecting POAF incidence.
  • Mediastinal, pleural, or chest wall surgery.
  • Reoperations or surgeries performed more than 48 hours prior.
  • Pregnant women.
  • Patients under guardians or similar legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Amiens

Amiens, 80054, France

RECRUITING

Related Publications (1)

  • Huette P, Beyls C, Diouf M, Ibrahima A, Haye G, Guilbart M, Lefebvre T, Bayart G, Lhotellier F, Radji M, Walczak KA, Caboche M, De Dominicis F, Georges O, Berna P, Merlusca G, Hermida A, Traulle S, Dupont H, Mahjoub Y, Abou-Arab O; THOFAWATCH Study Group. Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial). BMJ Open. 2025 Apr 9;15(4):e097765. doi: 10.1136/bmjopen-2024-097765.

    PMID: 40204329DERIVED

Study Officials

  • Pierre Huette, MD

    Centre Hospitalier Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Huette, MD

CONTACT

33322088371Huette.pierre@chu-amiens.fr

Study Design

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

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 9, 2024

Study Start

June 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)