Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-29 @ 7:31 AM
Study NCT ID:
NCT05019833
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2021-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signals timing vs LPEI', 'timeFrame': 'Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)', 'description': 'An exploratory analysis on the relation between timings derived from the signals acquired with CRT implanted devices, and LPEI (Left Pre-Ejection Interval) determined by echography in multiple configurations of atrio-ventricular (AV) and inter-ventricular (VV) delays.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters, in CRT patients.', 'detailedDescription': 'The SATURN study is a prospective, interventional, open-label, non-randomized, single-arm, acute, multicenter feasibility study.\n\nThe purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters.\n\nThe data collected will be analysed in order to explore the relevance of timings and morphological features derived from those signals in comparison with timings determined on echocardiography and electrocardiograms (ECG) in various configurations of atrioventricular (AV) and inter-ventricular (VV) delays.\n\nA maximum of 35 subjects, implanted with a CRT-D device, will be enrolled, at approximately 6 sites in France. Each patient will participate to this study only during an echocardiographic procedure, whose duration is estimated in approximately 1.5 hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with class I or II indication for implantation of a CRT-D device according to current ESC guidelines\n* Patient newly implanted with a MicroPort CRM Platinium CRT-D SonR or Platinium CRT-D device within 2 months before the Investigational Procedure\n* Patient in sinus rhythm with a preserved atrio-ventricular conduction, and PR interval=220 +/- 30 ms on surface ECG\n* Patient has reviewed, signed and dated the study informed consent form\n\nExclusion Criteria:\n\n* Patient with permanent or persistent atrial fibrillation or atrial flutter\n* Patient presenting with a permanent or frequent paroxysmal high degree atrio-ventricular block\n* Device upgrade or replacement\n* Minor patient (i.e. under 18 years of age), or patient under guardianship or kept in detention\n* Patient unavailable for the scheduled Investigational Procedure, not able to understand the purpose of this study or refusing to cooperate'}, 'identificationModule': {'nctId': 'NCT05019833', 'acronym': 'SATURN', 'briefTitle': 'Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort CRM'}, 'officialTitle': 'Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN', 'orgStudyIdInfo': {'id': 'ICRI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Signals collection', 'description': 'Collection of sensors signals by the implanted device.', 'interventionNames': ['Device: Signals collection']}], 'interventions': [{'name': 'Signals collection', 'type': 'DEVICE', 'description': 'A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.', 'armGroupLabels': ['Signals collection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bordachar Pierre', 'role': 'CONTACT'}, {'name': 'Bordachar Pierre, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mansourati Jacques', 'role': 'CONTACT'}, {'name': 'Mansourati Jacques, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel Laurent, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eicher Jean-Christophe, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Habib Gilbert', 'role': 'CONTACT'}, {'name': 'Habib Gilbert, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Deharo Jean-Claude, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Donal Erwan', 'role': 'CONTACT'}, {'name': 'Donal Erwan, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leclercq Christophe, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Da Costa Antoine', 'role': 'CONTACT'}, {'name': 'Da Costa Antoine, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU St Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Alberto Borri Brunetto', 'role': 'CONTACT', 'email': 'alberto.borri.brunetto@crm.microport.com', 'phone': '+39 335 6997104'}], 'overallOfficials': [{'name': 'Erwan Donal, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Pontchaillou - Rennes, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort CRM', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}