Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-30 @ 11:43 AM
Study NCT ID:
NCT05142293
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000556', 'term': 'Ambulatory Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 436}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-11-20', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medico-economic evaluation', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Cost-utility analysis to compare the efficiency of the same-day and overnight approaches.'}], 'primaryOutcomes': [{'measure': 'Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation.', 'timeFrame': 'over the 6-month follow-up duration', 'description': 'Number of Serious Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalisation', 'timeFrame': "Time between the patient's entry at the hospital and the patient's hospital discharge, an average of 2 days", 'description': 'Duration of hospitalisation in days'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'At baseline and 6 months of follow-up', 'description': 'The patient current health state will be estimated from the answers given by EuroQoL 5D (EQ-5D-5L) questionnaire. The EQ-5D-5L is a self-administered two-part instrument. The first part consists of 5 questions to assess current health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The second part is a 20 centimeters visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).'}, {'measure': 'Rate and reason for not selecting patient for a same-day procedure', 'timeFrame': 'during the implantation procedure hospitalization', 'description': 'Number and percentage of patients that were not selected for same-day procedure and the reason why they were not selected for same-day procedure through a questionnaire'}, {'measure': 'Rate and reason for conversion', 'timeFrame': 'during the implantation procedure hospitalization', 'description': 'Number and percentage of patients that were initially elective to same-day procedure but who finally were hospitalized for at least one night and the reason why they were converted to full hospitalization through a questionnaire'}, {'measure': 'Rate of transmitted data by Home Monitoring', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Number and percentage of data that were transmitted through the Home Monitoring technology'}, {'measure': 'Occurence of atrial and ventricular arrhythmias as detected by Home Monitoring', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Number of atrial and ventricular arrhythmias as detected by Home Monitoring'}, {'measure': 'Number of persons in charge of analyzing the Home Monitoring data', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Number of persons in charge of analyzing the Home Monitoring data in each site'}, {'measure': 'Description of the basic programming of the pacemaker', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Description of the mode that has been chosen by the physician to program the pacemaker'}, {'measure': 'All serious adverse events including patient deaths; all adverse device effects; all cardiovascular adverse events; all device deficiencies', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Number of each'}, {'measure': 'Chronotropic incompetence and influence of closed loop stimulation on the cardiac resynchronization therapy efficacy', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Description of the programmation of the chronotropic incompetence'}, {'measure': 'Rate of patients that performed stress tests', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Number and percentage of patients that performed stress tests'}, {'measure': 'Patient self-assessment', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Description of the patient self-assessment during follow-ups through a questionnaire : Markedly improved Moderately improved Slightly improved Remained unchanged Slightly worsened Moderately worsened Markedly worsened'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis', 'detailedDescription': 'The objective of the study is to show in the French centers selected for the same-day organization that a same-day CRT-P implantation is safe, feasible, and associated with significant cost-saving and a minimum conversion rate to full hospitalization by comparing outcomes with patients routinely hospitalized for at least one night. The medical economic evaluation will be based on the SNDS (National Health Data System) analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Only patients with an indication for a CRT-P system according to current clinical practice and who are already planned to be implanted with a CRT system according to the investigator's decision may be enrolled in this submodule.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned de novo implantation or upgrade to a Cardiac Resynchronization Therapy Pacemaker system according to the intended use\n* Patient is able to understand the nature of the registry and has provided written informed consent for BIO\\|STREAM.HF (heart failure registry) and the registry-based trial BIO\\|OEDIPE.CRT-P\n* Patient enrolled in BIO\\|STREAM.HF (heart failure registry)\n\nExclusion Criteria:\n\n* Patients in emergency situation or without medical assessment before hospitalisation for implantation\n* Patients previously implanted with an implantable cardiac defibrillator system\n* Patients with an implantable cardiac defibrillator indication\n* Patients planned to be implanted with an epicardial left ventricular lead (not implanted via the coronary sinus)\n* Patients planned to be implanted with His bundle pacing system'}, 'identificationModule': {'nctId': 'NCT05142293', 'acronym': 'OEDIPE-CRT-P', 'briefTitle': 'One Day Implantation Program for Heart Failure Patients Implanted With CRT-P', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers', 'orgStudyIdInfo': {'id': 'CR027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sites selected for the same-day organisation', 'description': 'Patients will be admitted to the hospital and leave it on the same-day of the procedure.', 'interventionNames': ['Other: Ambulatory procedure']}, {'label': 'Sites with standard overnight hospitalization', 'description': "Standard organisation with a minimum of one night's stay"}], 'interventions': [{'name': 'Ambulatory procedure', 'type': 'OTHER', 'description': 'In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process', 'armGroupLabels': ['Sites selected for the same-day organisation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bayonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas WELTE', 'role': 'CONTACT'}], 'facility': 'GCS Centre de Cardiologie du Pays Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques MANSOURATI', 'role': 'CONTACT'}], 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre OLLITRAULT', 'role': 'CONTACT'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chartres', 'status': 'TERMINATED', 'country': 'France', 'facility': 'Hôpital Louis Pasteur', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'city': 'Limoges', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'CHU Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lomme', 'status': 'TERMINATED', 'country': 'France', 'facility': 'Hôpital Saint Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Lorient', 'status': 'TERMINATED', 'country': 'France', 'facility': 'CH Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'city': 'Marseille', 'status': 'TERMINATED', 'country': 'France', 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Massy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mohammed-Salem YOUNSI', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'city': 'Melun', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyrus Moïni', 'role': 'CONTACT'}], 'facility': 'Clinique Les Fontaines', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc PASQUIE', 'role': 'CONTACT'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'status': 'TERMINATED', 'country': 'France', 'facility': 'Clinique du Millénaire', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Daniel GRAS', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Estelle Gandjbakhch', 'role': 'CONTACT'}], 'facility': 'Hôpital La Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pessac', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'CHU Haut Lévèque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine DA COSTA', 'role': 'CONTACT'}], 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Lô', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Michel', 'role': 'CONTACT'}], 'facility': 'CH Saint Lô', 'geoPoint': {'lat': 49.11624, 'lon': -1.09031}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence JESEL-MOREL', 'role': 'CONTACT'}], 'facility': 'Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'status': 'TERMINATED', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand PIERRE', 'role': 'CONTACT'}], 'facility': 'CHRU de Tours - Hôpital Trousseau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Valence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre GUIGNIER', 'role': 'CONTACT'}], 'facility': 'CH Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}], 'centralContacts': [{'name': 'Amandine Wouters', 'role': 'CONTACT', 'email': 'bio-oedipe@biotronik.com', 'phone': '+33(0)146759660'}, {'name': 'Julie Wallet', 'role': 'CONTACT', 'email': 'bio-oedipe@biotronik.com', 'phone': '+33(0)146759660'}], 'overallOfficials': [{'name': 'Jean-Luc Pasquié, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Jacques Mansourati, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}