Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-04 @ 4:33 AM
Study NCT ID:
NCT02828735
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiration Patterns With Impedance in LINQ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of respiration detection', 'timeFrame': 'up to 18 months', 'description': 'Respiratory Maneuvers and Device interrogation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breathing Exercises']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.\n* Chronic Kidney Disease (CKD) in Stage 5 (GFR = \\<15 mL/min).\n* Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).\n* Willing to sign the informed consent form.\n* Greater than 18 years of age.\n\nExclusion Criteria:\n\n* Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.\n* Significant respiratory diseases such as COPD or pulmonary hypertension.\n* Frequent arrhythmias, including PVC's.\n* Known systolic heart failure.\n* Recent infection.\n* Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method.\n* Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc).\n* Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.\n* Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest.\n* Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes.\n* Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study."}, 'identificationModule': {'nctId': 'NCT02828735', 'acronym': 'EPIQ', 'briefTitle': 'Respiration Patterns With Impedance in LINQ', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic BRC'}, 'officialTitle': 'REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor', 'orgStudyIdInfo': {'id': 'EPIQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Respiration assessment', 'interventionNames': ['Device: respiration assessment']}], 'interventions': [{'name': 'respiration assessment', 'type': 'DEVICE', 'description': 'Respiration Breathing Exercise', 'armGroupLabels': ['Respiration assessment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Mpiko Ntsekhe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groote Schuur Hospital, Cape Town, South Africa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic BRC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}