Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT04299360
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute improvement in cardiac function (1)', 'timeFrame': '24-48 hours after CRT-D implantation', 'description': 'change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time.'}, {'measure': 'Acute improvement in cardiac function (2)', 'timeFrame': '24-48 hours after CRT-D implantation', 'description': 'change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle.'}], 'secondaryOutcomes': [{'measure': 'Delayed response (1)', 'timeFrame': '3 Months', 'description': 'change in GLS. Participants will investigate whether left ventricular remodeling upon "patient-tailored" biventricular stimulation will behave differentially according to type of stimulation; the total amount of CRT-responder patients will be therefore considered'}, {'measure': 'Delayed response (2)', 'timeFrame': '3 Months', 'description': 'change in NYHA class. Participants will check if functional status will change after optimized biventricular stimulation therapy and will provide clinical data on CRT responders.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Resynchronization Therapy']}, 'referencesModule': {'references': [{'pmid': '38237796', 'type': 'DERIVED', 'citation': 'Passafaro F, Rapacciuolo A, Ruocco A, Ammirati G, Crispo S, Pasceri E, Santarpia G, Mauro C, Esposito G, Indolfi C, Curcio A. COMPArison of Multi-Point Pacing and ConvenTional Cardiac Resynchronization Therapy Through Noninvasive Hemodynamics Measurement: Short- and Long-Term Results of the COMPACT-MPP Study. Am J Cardiol. 2024 Mar 15;215:42-49. doi: 10.1016/j.amjcard.2023.12.057. Epub 2024 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines\n\nExclusion Criteria:\n\n* Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF\n* NYHA IV patients\n* Right Bundle Branch Block'}, 'identificationModule': {'nctId': 'NCT04299360', 'acronym': 'COMPACT-MPP', 'briefTitle': 'Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro'}, 'officialTitle': 'Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment', 'orgStudyIdInfo': {'id': '178'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'standard BIV', 'description': 'the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes.'}, {'label': 'MPP BIV', 'description': 'Such modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation.', 'interventionNames': ['Device: Cardiac Resynchronization Therapy device programming']}], 'interventions': [{'name': 'Cardiac Resynchronization Therapy device programming', 'type': 'DEVICE', 'description': 'Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively', 'armGroupLabels': ['MPP BIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': 'CZ', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Policlinico Mater Domini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '80100', 'city': 'Napoli', 'country': 'Italy', 'facility': 'AO Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80100', 'city': 'Napoli', 'country': 'Italy', 'facility': 'AOU Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Cardiology', 'investigatorFullName': 'Antonio Curcio', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro'}}}}