Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT04971993
Status:
TERMINATED
Last Update Posted:
2023-12-13
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Step and Walking Pattern From Cardiac Monitor Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Resourcing challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step Detection', 'timeFrame': '12 months', 'description': 'Characterize step count in class II and III heart failure and in ICM indicated patients with no history of heart failure.'}, {'measure': 'Walking Patterns', 'timeFrame': '12 months', 'description': 'Characterize walking patterns in class II and III heart failure and in ICM indicated patients with no history of heart failure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'walk'], 'conditions': ['Heart Failure NYHA Class II', 'Heart Failure NYHA Class III', 'Insertable Cardiac Monitor']}, 'descriptionModule': {'briefSummary': 'To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.', 'detailedDescription': 'This is a non-randomized, feasibility study that will enroll up to 60 participants diagnosed with Class II (30-35%) or III (30-35%) heart failure or are indicated for an insertable cardiac monitor with no history of heart failure (30-35%).\n\nThere will be one study visit per participant and a follow up phone call. The study visit includes device placement and data collection during rest and during a 6 minute hall walk. The device will then be removed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are diagnosed with NYHA class II heart failure, class III heart failure or are indicated for an ICM with no history of heart failure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 18 years or older\n* Willing and capable to provide written informed consent and agrees to participate in all protocol required activities\n* Subjects must meet one of the following criteria:\n* Documented New York Heart Association (NYHA) class II or III heart failure within the last 6 months\n\nOR\n\n* Subjects that have a known heart condition (non-heart failure) and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain and/or shortness of breath\n\nExclusion Criteria:\n\n* Not able to walk continuously for a period of 6 minutes at the subjects baseline walking speed\n* Prior hospitalization or surgery that affects the subjects baseline walking speed at time of enrollment\n* Cardiovascular event such as unstable angina or myocardial infarction that affects the subjects baseline walking speed at time of enrollment\n* Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system\n* Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)\n* Subject is pregnant as indicated by subject report and/or medical record at the time of enrollment\n* Subjects with rash or open wound on torso locations where investigational devices will be placed\n* Have an active implantable device\n* Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator\n* Any medical signs or symptoms that in the opinion of the investigator could represent a risk for the subject (I.e. increased baseline blood pressure or heart rate).'}, 'identificationModule': {'nctId': 'NCT04971993', 'acronym': 'SWAN', 'briefTitle': 'Step and Walking Pattern From Cardiac Monitor Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Step and Walking Pattern From Cardiac Monitor Study', 'orgStudyIdInfo': {'id': 'C2168'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart Failure NYHA Class II', 'description': 'Participants are diagnosed with NYHA Class II heart failure.', 'interventionNames': ['Device: Wearable Cardiac Monitor']}, {'label': 'Heart Failure NYHA Class III', 'description': 'Participants are diagnosed with NYHA Class III heart failure.', 'interventionNames': ['Device: Wearable Cardiac Monitor']}, {'label': 'At risk for arrythmias', 'description': 'Participants are indicated for an insertable cardiac monitor with no history of heart failure.', 'interventionNames': ['Device: Wearable Cardiac Monitor']}], 'interventions': [{'name': 'Wearable Cardiac Monitor', 'type': 'DEVICE', 'description': 'Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.', 'armGroupLabels': ['At risk for arrythmias', 'Heart Failure NYHA Class II', 'Heart Failure NYHA Class III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56303', 'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CentraCare Heart and Vascular Clinic', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}], 'overallOfficials': [{'name': 'Jamie Pelzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CentraCare Heart and Vascular Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}