Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-12 @ 5:27 AM
Study NCT ID:
NCT02064751
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2014-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2014-02-14', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure changes in hemodynamics during BiV pacing and MPP', 'timeFrame': 'up to 6-months'}], 'secondaryOutcomes': [{'measure': 'echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements', 'timeFrame': '6 months', 'description': 'End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system\n* Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines\n* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule\n\nExclusion Criteria:\n\n* Have persistent or permanent atrial fibrillation\n* Have a recent myocardial infarction within 40 days prior to enrollment\n* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months\n* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment\n* Have had intravenous inotropic support in the last 30 days\n* Be scheduled or considered for heart transplantation over the next 12 months\n* Be less than 18 years of age\n* Be pregnant or plan to become pregnant over the next 12 months'}, 'identificationModule': {'nctId': 'NCT02064751', 'briefTitle': 'MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients', 'orgStudyIdInfo': {'id': 'CRD_704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MultiPoint Pacing', 'description': 'CRT with MultiPoint Pacing', 'interventionNames': ['Device: CRT with MultiPoint Pacing', 'Procedure: Hemodynamic measurements for CRT device programming']}], 'interventions': [{'name': 'CRT with MultiPoint Pacing', 'type': 'DEVICE', 'armGroupLabels': ['MultiPoint Pacing']}, {'name': 'Hemodynamic measurements for CRT device programming', 'type': 'PROCEDURE', 'armGroupLabels': ['MultiPoint Pacing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Niguarda Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Christophe Leclercq, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Rennes, Rennes, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}