Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-07 @ 2:11 PM
Study NCT ID:
NCT05314218
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal quality', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Good signal amplitude and signal stability throughout the procedure without artefact'}], 'secondaryOutcomes': [{'measure': 'Micro-stimulation', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Micro-stimulation worked well.'}, {'measure': 'Manoeuvrability', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Ease of positioning and manoeuvrability the catheter (access to the desired area)'}, {'measure': 'Bending', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Link between the wheel and the bending for dynamic Xtrem and bending stability'}, {'measure': 'Imaging', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Visibility via X ray or 3D navigation.'}, {'measure': 'Diagnosis', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Diagnosis efficiency'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting.', 'detailedDescription': 'Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be included, patients must be:\n\n* 18 to 90 years old\n* Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias)\n* Informed and willing to sign an informed consent for approved by EC\n* Affiliation to the social security or foreign regime recognized in France\n\nExclusion Criteria:\n\nA patient will not be eligible to participate in the study if any of the following conditions are present:\n\n* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).\n* Any medical condition that could impact the study at investigator's discretion (e.g. allergy…).\n* Pregnant women\n* Adult subject to legal protection measure"}, 'identificationModule': {'nctId': 'NCT05314218', 'briefTitle': 'The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcis'}, 'officialTitle': 'EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis', 'orgStudyIdInfo': {'id': '2045-CIP_v1_01Feb2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Electrophysiology catheters and cables', 'type': 'DEVICE', 'description': 'The Xtrem electrophysiology catheter was developed for diagnosis of cardiac arrhythmias. Their function is to collect by contact, electrical signals generated by the heart muscle.\n\nXtrem are inserted via femoral vena cava or via artery and can be used in two occasions:\n\n* Exploration procedures for diagnosis alone\n* Diagnosis before ablation procedure An extension cable is used to connect the catheter to a stimulation/ recording device.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhône Durance', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Henri-Mondor AP-HP', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}