Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 11:17 AM
Study NCT ID:
NCT03127202
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phrenic nerve stimulation measurement', 'timeFrame': 'The presence of phrenic nerve stimulation will be assessed at implant.', 'description': 'The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization Therapy'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.', 'detailedDescription': 'The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.\n\nSuccess was defined as an absence of phrenic nerve stimulation (threshold \\> 7V) or in case of phrenic nerve stimulation occurrence (threshold \\< 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.\n\nAny occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for an implantation of a Cardiac Resynchronization Therapy-Defibrillator according to relevant regulations (will be only tolerated primo-implantation and upgrade)\n* Patient scheduled for implantation of a Cardiac Resynchronization Therapy-Defibrillator\n* Patient has given his informed consent\n\nExclusion Criteria:\n\n* Any contraindication for Implantable Cardioverter Defibrillator therapy\n* Heart transplantation or waiting for heart transplantation\n* Implanted with a ventricular assist device (VAD)\n* Inability to understand the purpose of the study or to cooperate\n* Not available for routine follow-up visits\n* Life expectancy less than 12 months\n* Age of less than 18 years and et pregnancy\n* Under guardianship'}, 'identificationModule': {'nctId': 'NCT03127202', 'acronym': 'ORPHEE', 'briefTitle': 'Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment', 'orgStudyIdInfo': {'id': 'RTSY01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac Resynchronization Therapy-Defibrillator', 'description': 'Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator', 'interventionNames': ['Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)']}], 'interventions': [{'name': 'Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)', 'type': 'DEVICE', 'description': "Patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator (model PARADYM RF SONR CRT-D 9770 or PARADYM RF CRT-D 9750, Sorin) having 3 left ventricular polarities. The choice of the right atrial, right ventricular and bipolar left ventricular leads was left to investigators' discretion.", 'armGroupLabels': ['Cardiac Resynchronization Therapy-Defibrillator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Annecy', 'country': 'France', 'facility': 'CH Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '62307', 'city': 'Lens', 'country': 'France', 'facility': 'CH LENS', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '56322', 'city': 'Lorient', 'country': 'France', 'facility': 'CH de Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13012', 'city': 'Marseille', 'country': 'France', 'facility': 'CHP Beauregard', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'facility': 'Polyclinique de Gentilly', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Groupe Hospitalo-universitaire Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'Hopital de La Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'country': 'France', 'facility': 'CH St Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Perpignan', 'country': 'France', 'facility': 'Clinique St Pierre', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}], 'overallOfficials': [{'name': 'Henri BENKEMOUN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Saint Pierre - Perpignan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LivaNova', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}