Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

NCT ID: NCT06724718

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Atrial Fibrillation Thoracic Surgery Smartwatches Rhythm Monitoring Cardiovascular Prognosis Asymptomatic Atrial Fibrillation Randomized Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Smartwatch group

Experimental intervention using smartwatches for rhythm monitoring.

Group Type EXPERIMENTAL

smartwatch

Intervention Type OTHER

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

ECG

Intervention Type OTHER

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

Control group

Standard care without smartwatch monitoring

Group Type ACTIVE_COMPARATOR

ECG

Intervention Type OTHER

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

Interventions

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smartwatch

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

Intervention Type OTHER

ECG

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Victor Pauchet

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Huette, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Amiens

Locations

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Centre hospitalier Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Huette, MD

Role: CONTACT

33322088371

Facility Contacts

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Pierre Huette, MD

Role: primary

33322088371

References

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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.

Reference Type DERIVED
PMID: 40204329 (View on PubMed)

Other Identifiers

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PI2023_843_0139

Identifier Type: -

Identifier Source: org_study_id

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