Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT07094256
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Torque Device Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Impedance', 'timeFrame': '15 minutes', 'description': 'Obtained from catheter at baseline and after Peritorq device placed'}, {'measure': 'Difference in Sensing of Chamber Amplitude (mV)', 'timeFrame': '15 minutes', 'description': 'Obtained from catheter at baseline and after Peritorq device placed'}, {'measure': 'Difference in Capture Threshold of Atrium and Ventricle (mA)', 'timeFrame': '15 minutes', 'description': 'Obtained from catheter at baseline and after Peritorq device placed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Electrophysiology Study', 'Ablation']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. All electrophysiology studies and/or ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patient (≤21 years of age)\n* Undergoing clinically-indicated electrophysiology study and/or ablation procedure\n\nExclusion Criteria:\n\n* Adult patient (\\>21 years)'}, 'identificationModule': {'nctId': 'NCT07094256', 'briefTitle': 'Torque Device Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Evaluation of Novel Torque Device During Electrophysiology Study Procedure', 'orgStudyIdInfo': {'id': 'PEDS-2024-33423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Torque Device', 'description': 'After the completion of the electrophysiology study and/or ablation procedure, the catheters remain in the intra-cardiac locations. While in place, measurements will be obtained from each catheter. Once the baseline measurements have been obtained, the Peritorq device will be placed onto each relevant catheter. Once secured, all measurements will be repeated with each catheter at the identical location. After measurements have been obtained, the operator will perform minor catheter movements to note subjective maneuverability and stability of the catheter with the torque device in place', 'interventionNames': ['Device: Peritorq']}], 'interventions': [{'name': 'Peritorq', 'type': 'DEVICE', 'description': 'Novel torque device specifically designed for electrophysiology and ablation catheters', 'armGroupLabels': ['Torque Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erick Jimenez', 'role': 'CONTACT', 'email': 'jimen191@umn.edu', 'phone': '612-626-2830'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Erick Jimenez', 'role': 'CONTACT', 'email': 'jimen191@umn.edu', 'phone': '612-626-2830'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}