Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 4:59 PM
Study NCT ID:
NCT04940156
Status:
TERMINATED
Last Update Posted:
2024-10-15
First Post:
2021-06-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Performance of ICM and CIED in Detecting AF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.varini@ouh.nhs.uk', 'phone': '01865220256', 'title': 'Dr Richard Varini', 'organization': 'Oxford University Hospitals NHS Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'OG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}], 'timeFrame': 'During follow-up (6 months)', 'description': 'To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'OG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}], 'timeFrame': 'During follow-up (6 months)', 'description': 'A comparison will be made between the percentage of change in R-wave amplitudes between both ICMs.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'To Compare the Transmission Success Rate of Both Devices.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'OG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}], 'timeFrame': 'During follow-up (6 months)', 'description': 'The percentage of successful transmission in both ICMs will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'To Compare the Number of Patient-activated Recordings That Contains Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'OG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}], 'timeFrame': 'During follow-up (6 months)', 'description': 'The percentage of patient-activated recordings with symptoms attributed to those episodes will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'FG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Confirm Rx', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.\n\nConfirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'BG001', 'title': 'LINQ', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.\n\nReveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Count of participants', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients recruited from Cardiac clinics'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-03', 'size': 876839, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-18T05:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Recruitment to study was insufficient. This was despite extending the recruitment period. Decision taken to terminate study due to lack of recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2021-06-17', 'resultsFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-22', 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED', 'timeFrame': 'During follow-up (6 months)', 'description': 'To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs.', 'timeFrame': 'During follow-up (6 months)', 'description': 'A comparison will be made between the percentage of change in R-wave amplitudes between both ICMs.'}, {'measure': 'To Compare the Transmission Success Rate of Both Devices.', 'timeFrame': 'During follow-up (6 months)', 'description': 'The percentage of successful transmission in both ICMs will be calculated.'}, {'measure': 'To Compare the Number of Patient-activated Recordings That Contains Symptoms.', 'timeFrame': 'During follow-up (6 months)', 'description': 'The percentage of patient-activated recordings with symptoms attributed to those episodes will be calculated.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Confirm Rx', 'Reveal LINQ'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to study the performance of the two most commonly used Implantable Cardiac Monitors in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care.', 'detailedDescription': "Atrial fibrillation (AF) is the most common abnormal heart rhythm disturbance, affecting 1-2 million people in the UK. The irregular heartbeat caused by AF can make the heart pump blood less efficiently. As a result, AF significantly increases the risk of having a stroke, heart failure and dementia. However, a significantly proportion of people have no symptoms, and they may be only found to be in AF after having a stroke. Therefore, diagnosis largely relies on accurate electrocardiogram (ECG) monitoring.\n\nAF episodes can be unpredictable and easily missed unless continuous ECG monitoring is undertaken. Pacemakers can continuously record the heart's electrical activity and detect AF with a high degree of confidence. However, they are invasive and rely on electrical wires implanted inside the heart, and hence less suited to be used as primary monitoring devices. To overcome these difficulties, implantable cardiac monitors (ICM) have been designed to be placed under the skin.\n\nThe new generation of ICMs can now be injected under the skin. Moreover, they connect with the patient's smartphone and transmit recordings. Despite these significant improvements, their ability to reliably capture AF has never been tested against pacemakers.\n\nThe aim of this project is to study the performance of the two commonly used ICMs in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care. The investigators plan to inject an ICM in 30 patients with AF and pre-existing pacemaker. After a period of 6 months, the investigators will compare how many episodes were detected in each device. With the information collected the investigators will try to understand the pitfalls in the current technology and develop strategies to improve it.\n\nAccurate, minimally invasive long-term ECG monitor can have far reaching benefits for patients, both in routine clinical practice and research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial.\n* Male or Female.\n* Aged 18 years or above.\n* History of paroxysmal and persistent AF.\n* Dual-chamber pacemaker, Implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy (CRT) device with a functioning atrial lead, able to record electrograms and remote monitoring.\n\nExclusion Criteria:\n\n* Diagnosis of permanent AF.\n* Contra-indications for implantable cardiac monitor.\n* Unable to comply with the follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT04940156', 'acronym': 'ID-AF', 'briefTitle': 'Comparison of the Performance of ICM and CIED in Detecting AF', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Comparison of the Performance of Implantable Cardiac Monitors and Cardiac Implantable Electronic Devices in Detecting Atrial Fibrillation', 'orgStudyIdInfo': {'id': '14558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients implanted with the Abbott Confirm Rx ICM', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.', 'interventionNames': ['Device: Confirm Rx (Implantable Cardiac Monitor)']}, {'type': 'OTHER', 'label': 'Patients implanted with the Medtronic LINQ ICM', 'description': 'Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.', 'interventionNames': ['Device: Reveal LINQ (Implantable Cardiac Monitor)']}], 'interventions': [{'name': 'Confirm Rx (Implantable Cardiac Monitor)', 'type': 'DEVICE', 'description': 'Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)', 'armGroupLabels': ['Patients implanted with the Abbott Confirm Rx ICM']}, {'name': 'Reveal LINQ (Implantable Cardiac Monitor)', 'type': 'DEVICE', 'description': 'Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)', 'armGroupLabels': ['Patients implanted with the Medtronic LINQ ICM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Tim Betts, MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Tim Betts MD MBChB FRCP', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}