Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-09 @ 6:08 PM
Study NCT ID:
NCT02698150
Status:
UNKNOWN
Last Update Posted:
2017-09-11
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '6MWT (6-minute walking test)', 'timeFrame': 'Baseline'}, {'measure': '6MWT (6-minute walking test)', 'timeFrame': '1 month after Mitraclip implant'}, {'measure': '6MWT (6-minute walking test)', 'timeFrame': '6 months after Mitraclip implant'}, {'measure': '6MWT (6-minute walking test)', 'timeFrame': '12 months after Mitraclip implant'}], 'primaryOutcomes': [{'measure': 'Quality of life @ 12 months', 'timeFrame': '12 months', 'description': 'Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant'}], 'secondaryOutcomes': [{'measure': 'Quality of life @ baseline', 'timeFrame': 'Baseline (1 month before Mitraclip implant)', 'description': 'Quality of life assessed with the SF36v2 questionnaire at 1 month before Mitraclip implant'}, {'measure': 'Quality of life @ index procedure (end of the run-in phase)', 'timeFrame': 'pre Mitraclip implant', 'description': 'Quality of life assessed with the SF36v2 questionnaire at the time of the Mitraclip procedure'}, {'measure': 'Quality of life @ 1 month', 'timeFrame': '1 month after Mitraclip implant', 'description': 'Quality of life assessed with the SF36v2 questionnaire at 1 month after Mitraclip implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mitral regurgitation', 'Mitraclip', 'Remote monitoring', 'Wearables'], 'conditions': ['Mitral Regurgitation', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients with severe functional mitral regurgitation undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system.', 'detailedDescription': "The scope of the HERMES study is to investigate whether the information obtained by remote monitoring in patients with severe functional mitral regurgitation who have undergone transcatheter mitral valve edge-to-edge repair with the Mitraclip system may have the potential to guide treatment decisions at follow-up visits, and improve the quality of life. Candidates to the Mitraclip procedure on optimal medical therapy will be offered the opportunity to participate to the study by bringing home a tablet and a series of sensors and wearables to collect daily information on blood pressure, oxygen saturation, weight variation, heart rate, symptoms and compliance to therapy. These variables will be blinded, stored by the tablet and downloaded by the core institution at follow-up visits. Clinicians will be encouraged to use these data to guide their decisions, personalizing drug therapies and follow-up schedules to the individual patient's need. Patients that during the run-in phase (from enrollment to 30+-7 days) will have used the tablet for \\>66% of the days will undergo the Mitraclip procedure and continue to keep the tablet for up to 12 months (active group). Patients that during the run-in phase (from enrollment to 30+-7 days) will have not used the tablet for \\>66% of the days, will continue the study as a control group. Predefined clinical follow up assessments for collection of study endpoints will be at 1 month post Mitraclip, 6 months post Mitraclip and 12 months post Mitraclip. Quality of life, assessed by means of the SF36v2 questionnaire, will be assessed at enrollment, pre Mitraclip, at 1 month after Mitraclip and at 12 months after Mitraclip. A series of secondary endpoints, including 6MWT assessments and consumption of resources will be also assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe mitral regurgitation of functional etiology undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic while on optimal medical therapy (NYHA Class III-IV)\n* Mitral regurgitation of functional etiology\n* Suitable Mitraclip candidate\n* Life expectancy \\>12 months\n\nExclusion Criteria:\n\n* Mitral regurgitation of primary etiology\n* Refusal to sign the informed consent\n* Dementia or neurological disorders that prevent the proper use of the tablet\n* Inability to use the tablet, the sensors and/or the wearables, even with the assistance of family members\n* Expected non-compliance with follow-up visits\n* End-stage chronic kidney disease on dialysis'}, 'identificationModule': {'nctId': 'NCT02698150', 'acronym': 'HERMES', 'briefTitle': 'Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Ferrarotto Alessi'}, 'officialTitle': 'Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System', 'orgStudyIdInfo': {'id': 'HERMES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remote monitoring', 'description': 'Active group of patients undergoing daily remote monitoring using sensors and wearables', 'interventionNames': ['Device: HERMES tablet']}, {'label': 'Control', 'description': 'Control group of patients undergoing standard follow up wth no remote monitoring'}], 'interventions': [{'name': 'HERMES tablet', 'type': 'DEVICE', 'description': 'Tablet, sensors and wearables for daily collection of clinical data', 'armGroupLabels': ['Remote monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Corrado Tamburino, MD, PhD', 'role': 'CONTACT', 'email': 'tambucor@unict.it', 'phone': '390957436201'}], 'facility': 'Ferrarotto Hospital', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'centralContacts': [{'name': 'Corrado Tamburino, Professor', 'role': 'CONTACT', 'email': 'tambucor@unict.it'}, {'name': 'Laura Basile', 'role': 'CONTACT', 'email': 'cardiologia.fe@aou.ct.it'}], 'overallOfficials': [{'name': 'Corrado Tamburino, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ferrarotto Hospital, University of Catania'}, {'name': 'Carmelo Grasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ferrarotto Hospital, University of Catania'}, {'name': 'Davide Capodanno, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ferrarotto Hospital, University of Catania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Ferrarotto Alessi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Davide Capodanno', 'investigatorAffiliation': 'Azienda Ospedaliero, Ferrarotto Alessi'}}}}