Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06772493
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ViewFlex X ICE First-in-Human Study
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.', 'timeFrame': 'During the procedure'}, {'measure': 'Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.', 'timeFrame': 'during the procedure'}, {'measure': 'Rate of device- or procedure-related serious adverse events that occur through patient discharge.', 'timeFrame': 'during the procedure and periprocedurally'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intracardiac Echocardiography', 'cardiac electrophysiology'], 'conditions': ['Cardiac Arrhythmias']}, 'descriptionModule': {'briefSummary': 'This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nA patient will be eligible for clinical trial participation if they meet the following criteria:\n\n1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.\n2. Plans to undergo any EP procedure utilizing ICE\n3. At least 18 years of age\n\nExclusion Criteria:\n\nA patient will be excluded from enrollment in the study if they meet any of the following criteria:\n\n1. Subject is currently participating in another clinical investigation.\n2. Implanted left atrial appendage occluder\n3. Implanted mechanical mitral or tricuspid valve replacement\n4. Implanted intracardiac device within 30 days\n5. Pregnant or nursing\n6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results."}, 'identificationModule': {'nctId': 'NCT06772493', 'acronym': 'ViewFlex X FIH', 'briefTitle': 'ViewFlex X ICE First-in-Human Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'ViewFlex X ICE First-in-Human Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System', 'interventionNames': ['Device: ViewFlex X ICE System']}, {'label': 'Cohort 2', 'description': 'Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System', 'interventionNames': ['Device: ViewFlex X ICE System']}], 'interventions': [{'name': 'ViewFlex X ICE System', 'type': 'DEVICE', 'description': 'Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kayla Rubino', 'role': 'CONTACT', 'email': 'krubino@dnairresearch.com', 'phone': '870-935-6729'}, {'name': 'Devi Nair, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Bernards Medical Center', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kendall Oliver', 'role': 'CONTACT', 'email': 'k4oliver@health.ucsd.edu', 'phone': '858-246-0217'}, {'name': 'Jonathan Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'Donita.Atkins@HCAHealthcare.com', 'phone': '(913) 934-4300'}, {'name': 'Rakesh Gopinathannair, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'April Jacob', 'role': 'CONTACT', 'email': 'april.jacob@nyulangone.org', 'phone': '212-263-7704'}, {'name': 'Larry Chinitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chandler Schwede', 'role': 'CONTACT', 'email': 'schwede@musc.edu', 'phone': '843-792-5998'}, {'name': 'Jeffrey Winterfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Ben Gansemer, PhD', 'role': 'CONTACT', 'email': 'benjamin.gansemer@abbott.com', 'phone': '9527152719'}, {'name': 'Anne Sarver, PhD', 'role': 'CONTACT', 'email': 'anne.sarver@abbott.com'}], 'overallOfficials': [{'name': 'Kristin Ruffner, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}