Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT03398369
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2018-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanistic Clinical Trial of Advanced Imaging for CRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2018-01-07', 'studyFirstSubmitQcDate': '2018-01-07', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular end-systolic volume (LVESV) improvement', 'timeFrame': 'One Year', 'description': 'Change in LVESV with cardiac resynchronization therapy (CRT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure, Systolic']}, 'descriptionModule': {'briefSummary': 'This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.', 'detailedDescription': 'At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic systolic HF\n2. LVEF 35% or less\n3. Guideline-based class I or II indication for CRT\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Pregnancy\n3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging\n4. Cerebral aneurysm clips\n5. Cochlear implants\n6. Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)\n7. Severe claustrophobia\n8. Acute kidney injury\n9. Acute renal failure or chronic kidney disease with GFR \\< 45 cc/min/1.73m2\n10. Liver transplant\n11. Gadolinium allergy\n12. \\>10% premature ventricular contraction (PVC) burden; and 13) estimated \\>10% atrial fibrillation (AF) burden based on available clinical data.'}, 'identificationModule': {'nctId': 'NCT03398369', 'briefTitle': 'Mechanistic Clinical Trial of Advanced Imaging for CRT', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT', 'orgStudyIdInfo': {'id': 'UVAMRICRTTRIAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'CMR-Guided CRT', 'interventionNames': ['Diagnostic Test: CMR/CTA Guidance for CRT']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard CRT'}], 'interventions': [{'name': 'CMR/CTA Guidance for CRT', 'type': 'DIAGNOSTIC_TEST', 'description': 'The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Hoover', 'role': 'CONTACT', 'email': 'jrh5r@hscmail.mcc.virginia.edu', 'phone': '434-243-4861'}], 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Kenneth C Bilchick, MD', 'role': 'CONTACT', 'email': 'bilchick@virginia.edu', 'phone': '4349242465'}, {'name': 'Hollis Phillips, BA', 'role': 'CONTACT', 'email': 'hp9r@hscmail.mcc.virginia.edu', 'phone': '434-243-0046'}], 'overallOfficials': [{'name': 'Kenneth C Bilchick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Kenneth Bilchick, MD', 'investigatorAffiliation': 'University of Virginia'}}}}