Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT03557034
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}}}}, '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': 'TARAKJK@ccf.org', 'phone': '216-445-9225', 'title': 'Khaldoun Tarakji, MD, MPH', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit.", 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software.", 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Atrial Fibrillation Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'OG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'classes': [{'categories': [{'measurements': [{'value': '85.0', 'spread': '62.8', 'groupId': 'OG000'}, {'value': '77.6', 'spread': '61.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized Patients that did not withdraw consent immediately'}, {'type': 'SECONDARY', 'title': 'Incidence of Atrial Fibrillation After Successful AF Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'OG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number (%) participants with Afib detected after ablation and during the study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Atrial Fibrillation Episodes Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'OG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Number of abnormal reading using Kardia Mobile after ablation', 'unitOfMeasure': 'Number of abnormal reading', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Applies only to Kardia Mobile arm'}, {'type': 'SECONDARY', 'title': 'Average Number of Clinical Encounters After Successful Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'OG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Average number of phone encounters within 6 months after successful ablation', 'unitOfMeasure': 'Number of phone encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients that did not withdraw consent immediately'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Alternative Monitoring Devices After Successful Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'OG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'OG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.23', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '0.17'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Generalized Anxiety Disorder-7 is a scale to measure the severity of anxiety. It consists of asking patients to respond to a simple questionnaire and each answer is assigned a point based on the frequency of a given symptom (0=Not at all, 1=Several days, 2= More than half the days, 3=Nearly everyday). Total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. A total score of 5-9 indicates mild anxiety, 10-14 moderate anxiety, and \\>15 severe anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care Monitoring', 'description': 'Standard of Care: Patients will be followed clinically based on symptoms.'}, {'id': 'FG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care Monitoring', 'description': "Standard of Care\n\nThis is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."}, {'id': 'BG001', 'title': 'Kardia Monitoring', 'description': "Kardia Mobile/Kardia Pro\n\nKardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '95', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Afib at baseline', 'classes': [{'categories': [{'title': 'Paroxysmal', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Persistent', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CHADS-VASC score', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score is a validated tool to predict the risk of stroke and systemic emboli in patients with non-valvular atrial fibrillation. Score ranges 0 - 6. Oral anticoagulation is recommended for those patients with a score of 2 or greater, and oral anticoagulant or aspirin may be considered for a CHA2DS2-VASc score of 1.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Randomized patients that did not withdraw consent early'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-28', 'size': 841997, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-19T16:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2018-06-04', 'resultsFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-14', 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Atrial Fibrillation Detection', 'timeFrame': '6 months', 'description': 'This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Atrial Fibrillation After Successful AF Ablation', 'timeFrame': '6 months', 'description': 'Number (%) participants with Afib detected after ablation and during the study period.'}, {'measure': 'Number of Atrial Fibrillation Episodes Detected', 'timeFrame': '6 months', 'description': 'Number of abnormal reading using Kardia Mobile after ablation'}, {'measure': 'Average Number of Clinical Encounters After Successful Ablation', 'timeFrame': '6 months', 'description': 'Average number of phone encounters within 6 months after successful ablation'}, {'measure': 'Number of Participants Using Alternative Monitoring Devices After Successful Ablation', 'timeFrame': '6 months', 'description': 'Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval'}, {'measure': 'Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period', 'timeFrame': '6 months', 'description': 'The Generalized Anxiety Disorder-7 is a scale to measure the severity of anxiety. It consists of asking patients to respond to a simple questionnaire and each answer is assigned a point based on the frequency of a given symptom (0=Not at all, 1=Several days, 2= More than half the days, 3=Nearly everyday). Total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. A total score of 5-9 indicates mild anxiety, 10-14 moderate anxiety, and \\>15 severe anxiety.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pulmonary vein isolation', 'atrial fibrillation', 'remote monitoring', 'heart rhythm monitor'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Pulmonary vein isolation is a widely used strategy for the treatment of patients with symptomatic atrial fibrillation. After successful pulmonary vein isolation (no atrial fibrillation on transtelephonic rhythm recordings for 3 months following ablation), heart rhythm is not routinely monitored. The goal of this study is to determine whether the Kardia Mobile device detects AF at a different rate compared to our standard of care. The study also hopes to understand how this Kardia Mobile device and Kardia Pro platform affect health care utilization and patient anxiety.', 'detailedDescription': "Pulmonary vein isolation (PVI) is a widely used strategy for the treatment of patients with symptomatic atrial fibrillation (AF). After ablation, patients are usually discharged with transtelephonic monitor. Patients are encouraged to send their electrophysiologist transmissions of their heart rhythm at least once a week or anytime they have symptoms. After 3-4 months of remote monitoring, patients come for their first visit after the ablation. At this visit, the electrophysiologist reviews the heart rhythm transmissions since the ablation and based on the findings, decisions are made regarding anticoagulation or antiarrhythmic drug therapy. If all transmissions show sinus rhythm and the patient is doing well, he or she is normally followed clinically based on symptoms without any rhythm monitors. Usually, these patients follow up in another 6 months with an ECG at the time of the visit with the caring electrophysiologist. During these 6 months, patients might experience palpitations or recurrent arrhythmias. These episodes usually trigger phone encounters with the provider and this can trigger additional testing. Sometimes it might lead to clinic or emergency room encounters.\n\nKardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software. The goal of our study is to determine whether detection of AF with Kardia Mobile is different than the current standard approach and to assess the value of using Kardia Mobile and the KardiaPro platform in decreasing health care utilization and reducing patient anxiety following AF ablation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-85 years old\n2. Have smartphone with data plan\n3. History of AF (paroxysmal or persistent)\n4. In sinus rhythm at the 3-4 month post-procedure visit and no evidence of AF during the interval starting after the 3 week blanking period and ending at the appointment time.\n5. On Anticoagulation if CHADS VASC score is ≥ 1 and will continue to be on anticoagulation or CHADS VASC of Zero\n6. Willing to follow up with their Cleveland Clinic electrophysiologist in 6 months\n\nExclusion Criteria:\n\n1. Patients without smartphone\n2. Unwilling to provide consent\n3. Unwilling to follow up in 6 months\n4. CHADS VASC ≥ 1 and anticoagulation will be stopped\n5. Presence of a cardiac implantable electronic device\n6. If the primary electrophysiologist decides the patient still needs monitoring through traditional monitors due to any reason'}, 'identificationModule': {'nctId': 'NCT03557034', 'acronym': 'AliveCor', 'briefTitle': 'A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure', 'orgStudyIdInfo': {'id': '18-444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care Monitoring', 'description': 'Standard of Care'}, {'type': 'EXPERIMENTAL', 'label': 'Kardia Monitoring', 'description': 'Kardia Mobile/Kardia Pro', 'interventionNames': ['Device: Kardia Monitoring']}], 'interventions': [{'name': 'Kardia Monitoring', 'type': 'DEVICE', 'description': "Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software.", 'armGroupLabels': ['Kardia Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Khaldoun G Tarajki, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'AliveCor', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}