Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT01821651
Status:
UNKNOWN
Last Update Posted:
2013-06-19
First Post:
2012-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Dose (mSv) administered to each patient', 'timeFrame': 'Day of intervention (day 1)', 'description': 'At the end of the procedure the recorded radiation-dose is assessed.'}], 'secondaryOutcomes': [{'measure': 'Duration of the intervention (minutes)', 'timeFrame': 'Day of intervention (day 1)', 'description': 'At the end of the procedure the skin-to-skin-time is assessed.'}, {'measure': 'Contrast agent dose (ml)', 'timeFrame': 'Day of intervention (day 1)', 'description': 'At the end of the procedure the recorded contrast agent dose is assessed.'}, {'measure': 'Increased quality of care (EchoNav group)', 'timeFrame': 'Discharge: 1 to 5 days after intervention', 'description': 'Usually 1 to 5 days after intervention'}, {'measure': 'Degree of Mitral Regurgitation (EchoNav group)', 'timeFrame': 'Discharge: 1 to 5 days after intervention', 'description': 'Usually 1 to 5 days after intervention'}, {'measure': 'Postinterventional transvalvular gradient', 'timeFrame': 'Up to 7 days after intervention', 'description': 'Catheter-based direct measurement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TAVI', 'MitraClip', 'image modality', 'echocardiography', 'angiography'], 'conditions': ['Heart Valve Diseases']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nGoal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.\n\nBoth the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).\n\nThis pilot study aims at observing these aims on a small patient population and a control group.\n\nNumber of Subjects:\n\n140 patients total in 6 groups:\n\n* MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).\n* MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).\n* TAVI with HeartNavigator lead in (10)\n* TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).', 'detailedDescription': 'Medical Device:\n\nHeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.\n\nEchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male and female patients over 18 years of age.\n* Ability and willingness to give informed consent.\n* Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.\n* Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).\n\nExclusion criteria:\n\n* Contraindications on ethical grounds,\n* Women who are pregnant or breast feeding,\n* Emergency cases,\n* Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,\n* Known renal insufficiency (GFR \\< 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),\n* Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),\n* Known or suspected drug or alcohol abuse,\n* Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,\n* Patient is unable or unwilling to cooperate with the study protocol.'}, 'identificationModule': {'nctId': 'NCT01821651', 'briefTitle': 'Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room', 'orgStudyIdInfo': {'id': 'HOR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HeartNavigator', 'description': 'Group with HeartNavigator-Software', 'interventionNames': ['Device: HeartNavigator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control-group without HeartNavigator-Software', 'interventionNames': ['Other: Control-group HN']}, {'type': 'EXPERIMENTAL', 'label': 'EchoNav', 'description': 'Group with EchoNav-Software', 'interventionNames': ['Device: EchoNav']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conrol', 'description': 'Control-group without EchoNav-Software', 'interventionNames': ['Other: Control-Group EN']}], 'interventions': [{'name': 'HeartNavigator', 'type': 'DEVICE', 'otherNames': ['HeartNavigator, procedure with software'], 'description': 'Procedure with software', 'armGroupLabels': ['HeartNavigator']}, {'name': 'EchoNav', 'type': 'DEVICE', 'otherNames': ['EchoNav, procedure with software'], 'description': 'Procedure with software', 'armGroupLabels': ['EchoNav']}, {'name': 'Control-Group EN', 'type': 'OTHER', 'otherNames': ['Compare to EchoNav-group'], 'description': 'Procedure without software', 'armGroupLabels': ['Conrol']}, {'name': 'Control-group HN', 'type': 'OTHER', 'otherNames': ['Compare to HeartNavigator-group'], 'description': 'Procedure without software', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Cardiovascular Surgery', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Simon Sündermann, MD', 'role': 'CONTACT', 'email': 'simon.suendermann@usz.ch'}, {'name': 'Volkmar Falk, Prof MD', 'role': 'CONTACT', 'email': 'volkmar.falk@usz.ch'}], 'overallOfficials': [{'name': 'Volkmar Falk, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Cardiovascular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}