Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-02 @ 9:07 AM
Study NCT ID:
NCT06647459
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-12', 'size': 1240330, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-03T13:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VT Inducibility', 'timeFrame': 'At the time of procedure', 'description': 'The primary endpoint is induction of sustained VT that is determined to be reentrant or likely-reentrant. Sustained VT will be defined as VT lasting 30 seconds or requiring termination with burst pacing or cardioversion due to hemodynamic instability.'}, {'measure': 'Presence of ventricular arrhythmias per specific site', 'timeFrame': 'At the time of procedure', 'description': 'The primary endpoint is the occurrence (yes/no) of ventricular arrhythmias (PVCs, NSVT, sustained VT) that are mapped to the basal LV as defined above.'}, {'measure': 'Low voltage substrate', 'timeFrame': 'At the time of procedure', 'description': 'The primary endpoint is the presence of low voltage (yes/no) in the basal LV.'}], 'secondaryOutcomes': [{'measure': 'Site of origin for ventricular arrhythmias', 'timeFrame': 'At the time of procedure', 'description': 'Secondary analyses will explore the rate of ventricular arrhythmias in other segments of the LV and RV and will compare the site of origin for ventricular arrhythmias in the group of participants with pathogenic variants in other CM genes.'}, {'measure': 'Evaluation of electrogram potentials', 'timeFrame': 'At the time of procedure', 'description': 'Secondary analyses will explore multicomponent electrograms and fractionated potentials that can be created by scar.'}, {'measure': 'Presence of low voltage', 'timeFrame': 'At the time of procedure', 'description': 'Other secondary analyses will compare the presence of low voltage and the other secondary endpoints in the group of participants with pathogenic variants in other CM genes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['catheter ablation', 'genomics'], 'conditions': ['Ventricular Tachycardia', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.', 'detailedDescription': 'Participants will undergo AF ablation according to standard, contemporary techniques. The procedure will be performed under general anesthesia. As part of routine standard of care in patients with early-onset AF or patients who have PVCs, we will also test for inducibility of VT using a standardized pacing protocol. The research protocol will include LV mapping and identification of low voltage substrate using electroanatomical mapping as described below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with early-onset AF are referred to our Vanderbilt AF Precision Medicine Clinic and undergo clinical genetic testing with a CM/arrhythmia panel and a comprehensive clinical evaluation including a cardiac MRI. 50% of patients are referred to undergo AF ablation to treat symptomatic AF. For all eligible patients, the study will be described either in person, or be contacted via phone with an approved phone script. If interested, participants sign the written informed consent (paper option or e-consent option).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults aged 18 and older\n2. Diagnosed with AF before age 60\n3. Scheduled for catheter-based AF ablation (de-novo or repeat)\n4. Able to provide written, informed consent\n5. P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control.\n\nExclusion Criteria:\n\n1. Diagnosed with a genetic CM or arrhythmia syndrome prior to AF\n2. VUS in 'possibly pathogenic' subgroup (control group only)\n3. Pacemaker or ICD\n4. Previous PVC or VT ablation\n5. LVEF \\<20%\n6. Prosthetic mitral or aortic valve\n7. Contraindication to heparin\n8. Prior myocardial infarction."}, 'identificationModule': {'nctId': 'NCT06647459', 'briefTitle': 'Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial', 'orgStudyIdInfo': {'id': '231260'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pathogenic variant in TTN', 'description': '50 patients with a pathogenic variant in TTN', 'interventionNames': ['Diagnostic Test: EP Study']}, {'label': 'Pathogenic variant in other cardiomyopathy genes', 'description': '50 patients with a pathogenic variant in other cardiomyopathy genes', 'interventionNames': ['Diagnostic Test: EP Study']}, {'label': 'Genotype-negative controls', 'description': '100 genotype-negative controls', 'interventionNames': ['Diagnostic Test: EP Study']}], 'interventions': [{'name': 'EP Study', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Mapping'], 'description': 'To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.', 'armGroupLabels': ['Genotype-negative controls', 'Pathogenic variant in TTN', 'Pathogenic variant in other cardiomyopathy genes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dakota D Grauherr, RN', 'role': 'CONTACT', 'email': 'dakota.grauherr@vumc.org', 'phone': '615-714-8674'}, {'name': 'Diane M Crawford, RN', 'role': 'CONTACT', 'email': 'diane.m.crawford@vumc.org', 'phone': '615-981-2054'}, {'name': 'Moore B Shoemaker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William G Stevenson, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Dakota D Grauherr, RN', 'role': 'CONTACT', 'email': 'dakota.grauherr@vumc.org', 'phone': '615-714-8674'}, {'name': 'Diane M Crawford, RN', 'role': 'CONTACT', 'email': 'diane.m.crawford@vumc.org', 'phone': '615-981-2054'}], 'overallOfficials': [{'name': 'Moore B Shoemaker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'M. Benjamin Shoemaker', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}