Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT06724718
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 302}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of POAF', 'timeFrame': 'at day 7', 'description': 'the incidence of POAF within seven days after scheduled thoracic surgery.'}], 'secondaryOutcomes': [{'measure': 'Rate of asymptomatic POAF', 'timeFrame': 'at day 7', 'description': 'Rate of asymptomatic POAF, evaluated using the EHRA symptom score'}, {'measure': 'Cardiovascular prognosis', 'timeFrame': 'at day 3', 'description': 'Cardiovascular prognosis assessed through a composite outcome (MACE)'}, {'measure': 'Cardiovascular prognosis', 'timeFrame': 'at 6 months', 'description': 'Cardiovascular prognosis assessed through a composite outcome (MACE)'}, {'measure': 'Feasibility of rhythm monitoring with a smartwatch', 'timeFrame': 'at day 7', 'description': 'Feasibility of rhythm monitoring with a smartwatch, measured by device usage time and the proportion of successful single-lead ECGs performed.'}, {'measure': 'Recurrence of AF', 'timeFrame': 'at 3 months', 'description': 'Recurrence of AF'}, {'measure': 'Recurrence of AF', 'timeFrame': 'at 6 months', 'description': 'Recurrence of AF'}, {'measure': 'management of AF', 'timeFrame': 'at 3 months', 'description': 'management of AF'}, {'measure': 'management of AF', 'timeFrame': 'at 6 months', 'description': 'management of AF'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative atrial fibrillation', 'thoracic surgery', 'smartwatches', 'rhythm monitoring', 'cardiovascular prognosis', 'asymptomatic atrial fibrillation', 'randomized trial'], 'conditions': ['Postoperative Atrial Fibrillation', 'Thoracic Surgery', 'Smartwatches', 'Rhythm Monitoring', 'Cardiovascular Prognosis', 'Asymptomatic Atrial Fibrillation', 'Randomized Trial']}, 'referencesModule': {'references': [{'pmid': '40204329', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\>18 years old).\n* Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.\n* Scheduled pneumonectomy or lobectomy.\n* Admission to a conventional surgical unit postoperatively.\n* Ability to perform single-lead ECG using a smartwatch.\n* Coverage under a social security system.\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of atrial fibrillation.\n* Requirement for telemetry for AV block or tachyarrhythmias (\\>140 bpm).\n* Dependency on a pacemaker.\n* Participation in another interventional clinical trial affecting POAF incidence.\n* Mediastinal, pleural, or chest wall surgery.\n* Reoperations or surgeries performed more than 48 hours prior.\n* Pregnant women.\n* Patients under guardians or similar legal protection.'}, 'identificationModule': {'nctId': 'NCT06724718', 'acronym': 'THO-FA-WATCH', 'briefTitle': 'Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch', 'orgStudyIdInfo': {'id': 'PI2023_843_0139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartwatch group', 'description': 'Experimental intervention using smartwatches for rhythm monitoring.', 'interventionNames': ['Other: smartwatch', 'Other: ECG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard care without smartwatch monitoring', 'interventionNames': ['Other: ECG']}], 'interventions': [{'name': 'smartwatch', 'type': 'OTHER', 'description': 'Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch', 'armGroupLabels': ['Smartwatch group']}, {'name': 'ECG', 'type': 'OTHER', 'description': 'Detected POAF episodes will be confirmed via a 12-lead ECG', 'armGroupLabels': ['Control group', 'Smartwatch group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Huette, MD', 'role': 'CONTACT', 'email': 'Huette.pierre@chu-amiens.fr', 'phone': '33322088371'}, {'name': 'Christophe Beyls, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre hospitalier Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Pierre Huette, MD', 'role': 'CONTACT', 'email': 'Huette.pierre@chu-amiens.fr', 'phone': '33322088371'}], 'overallOfficials': [{'name': 'Pierre Huette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Amiens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinique Victor Pauchet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}