Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT07206602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI-Guided Left Bundle Branch Area Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRT response rate', 'timeFrame': 'Baseline, 6 months', 'description': 'CRT response is defined as an absolute increase of \\>5% in left ventricular ejection fraction (LVEF) after 6 months of CRT'}], 'secondaryOutcomes': [{'measure': 'NYHA (New York Heart Association) Class', 'timeFrame': 'Baseline, 6 months', 'description': 'The New York Heart Association (NYHA) classification will be assessed using the NYHA questionnaire, which evaluates the extent of physical limitations caused by heart failure. This system categorizes patients into one of four classes, with higher classes indicating more severe functional impairment.'}, {'measure': 'Number of Hospitalizations', 'timeFrame': '6 months', 'description': 'Number of Hospitalizations will be determined by the number of participants that are hospitalized for heart failure.'}, {'measure': 'Number of Deaths', 'timeFrame': '6 months', 'description': 'Number of patient deaths by any cause'}, {'measure': 'Left Ventricular Linear Dimensions', 'timeFrame': 'Baseline, 3 months', 'description': 'Left Ventricular Linear Dimensions will be measured by an echocardiogram. A lower value indicates better cardiac function.'}, {'measure': 'Left Ventricular Linear Volume', 'timeFrame': 'Baseline, 3 months', 'description': 'Left Ventricular Linear Volume will be measured by an echocardiogram. A lower value indicates better cardiac function.'}, {'measure': 'Procedural success: LBBAP-conventional arm', 'timeFrame': 'Baseline', 'description': 'LBBAP is considered successful if unipolar paced QRS morphology demonstrated a Qr or qR morphology in lead V1 along with any 1 of the following criteria:\n\n* Left bundle branch potential\n* Transition to selective left bundle branch capture or left ventricular septal capture during threshold testing or programmed stimulation\n* R-wave peak time \\<90 ms in V5-V6\n* V6-V1 interpeak interval \\>44 ms'}, {'measure': 'Procedural success: AI-LBBAP arm', 'timeFrame': 'Baseline', 'description': 'Procedural success is defined as improvement in the AI-ECG predicted likelihood of having a low LVEF from greater than 0.5 at baseline to less than 0.5 after LBBAP.'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'Baseline, Approximately 30 minutes', 'description': 'Fluoroscopy time will be determined by the amount of time that fluoroscopy is used to guide the left bundle branch area pacing (an average of 30 minutes)'}, {'measure': 'Total procedure time', 'timeFrame': 'Baseline, Approximately 1-2 hours', 'description': 'Total procedure time will be determined by the start of the LBBAP procedure until completion (an average of 2 hours)'}, {'measure': 'Lead pacing thresholds', 'timeFrame': 'Baseline', 'description': 'Lead pacing thresholds will be measured in Voltage at millisecond.'}, {'measure': 'Impedance', 'timeFrame': 'Baseline', 'description': 'Impedance will be measured in Ohms.'}, {'measure': 'Sensing Parameters', 'timeFrame': 'Baseline', 'description': 'Sensing Parameters will be measured in mV (milliVolts)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age: 18 years or older.\n* Left Ventricular Ejection Fraction (LVEF): \\<50% within 6 months prior to enrollment.\n* QRS Duration: Resting QRS duration ≥ 130 ms on ECG OR anticipated right ventricular pacing \\> 40% OR device in place with right ventricular pacing \\> 40% within 6 months prior to enrollment.\n* Medical Therapy: Optimized on guideline-directed medical therapy for heart failure.\n* AI-ECG probability of low LVEF: \\>0.5\n\nExclusion Criteria\n\n* Age less than 18 years old\n* Inability to follow-up\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07206602', 'briefTitle': 'AI-Guided Left Bundle Branch Area Pacing', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure', 'orgStudyIdInfo': {'id': '25-007700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-guided', 'interventionNames': ['Device: AI-assisted Left Bundle Branch Area Pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Procedure: Left Bundle Branch Area Pacing']}], 'interventions': [{'name': 'AI-assisted Left Bundle Branch Area Pacing', 'type': 'DEVICE', 'description': 'Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology', 'armGroupLabels': ['AI-guided']}, {'name': 'Left Bundle Branch Area Pacing', 'type': 'PROCEDURE', 'description': 'Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Sean Olson', 'role': 'CONTACT', 'email': 'olson.sean@mayo.edu', 'phone': '507-255-2811'}], 'overallOfficials': [{'name': 'Fatima Ezzeddine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatima M. Ezzeddine', 'investigatorAffiliation': 'Mayo Clinic'}}}}