Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05265520
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2022-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
His-Bundle Corrective Pacing in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002037', 'term': 'Bundle-Branch Block'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.', 'timeFrame': 'Up to 24 months', 'description': 'Assessing changes in QRS duration at 6, 12, 24 months in the His-CRT vs. BIV-CRT arm'}, {'measure': 'Heart failure (HF) or death events', 'timeFrame': 'Up to 24 months', 'description': 'Assess heart Failure (HF)/death rates in the His-CRT vs. BIV-CRT arm'}], 'primaryOutcomes': [{'measure': 'Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)', 'timeFrame': '6 month', 'description': 'The effect of His-CRT vs. BIV-CRT on left ventricular ejection fraction (as a percentage) measured during an echocardiography imaging study will be analyzed using an analysis of covariance model for changes in LVEF from pre-implantation (baseline) to post-implantation (6 months follow-up), with randomized treatment group as the factor of interest, and baseline LVEF as a covariate. A t-test will be performed using this model to compare the adjusted group means, and a confidence interval will be constructed for their difference.'}], 'secondaryOutcomes': [{'measure': 'Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers', 'timeFrame': '6 months', 'description': 'Secondary endpoint measured on a continuous scale of paced ventricular depolarization (QRS) duration in the His-CRT vs. BIV-CRT arm'}, {'measure': 'Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)', 'timeFrame': '6 months', 'description': 'Secondary endpoint measured from echocardiography on left ventricular end-systolic volume (LVESV) in the His-CRT vs. BIV-CRT arm'}, {'measure': 'Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)', 'timeFrame': '6 months', 'description': 'Secondary endpoint measured from echocardiography on left ventricular end-diastolic volume (LVEDV) in the His-CRT vs. BIV-CRT arm'}, {'measure': 'Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP', 'timeFrame': '6 months', 'description': 'Secondary endpoint of NT-proBNP in the His-CRT vs. BIV-CRT arm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Right Bundle-Branch Block', 'Heart Failure', 'His-bundle Pacing', 'Cardiac Resynchronization Therapy']}, 'descriptionModule': {'briefSummary': 'The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).', 'detailedDescription': 'In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older (no upper age limit)\n* Optimal medical therapy for heart failure by current guidelines\n* Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:\n\n * New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR\n * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR\n * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)\n\nExclusion Criteria:\n\n* Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization\n* Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology\n* Unable or unwilling to follow study protocol\n* Less than 12 months life expectancy at consent\n* Pregnancy or planned pregnancy during duration of the study\n* On heart transplant list or likely to undergo heart transplant'}, 'identificationModule': {'nctId': 'NCT05265520', 'acronym': 'HIS-CRT', 'briefTitle': 'His-Bundle Corrective Pacing in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'His-Bundle Corrective Pacing in Heart Failure', 'orgStudyIdInfo': {'id': 'STUDY 00007025'}, 'secondaryIdInfos': [{'id': '1R01HL153390-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL153390-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'His-CRT implantation', 'description': 'His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.', 'interventionNames': ['Procedure: His-CRT implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BIV-CRT implantation', 'description': 'BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.', 'interventionNames': ['Procedure: BIV-CRT implantation']}], 'interventions': [{'name': 'His-CRT implantation', 'type': 'PROCEDURE', 'description': 'The pathophysiological process is utilized in His-Bundle corrective pacing, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular endocardial lead.', 'armGroupLabels': ['His-CRT implantation']}, {'name': 'BIV-CRT implantation', 'type': 'PROCEDURE', 'description': 'Biventricular cardiac resynchronization therapy has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.', 'armGroupLabels': ['BIV-CRT implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shahram Sarrafi', 'role': 'CONTACT'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Michel', 'role': 'CONTACT'}], 'facility': 'Valley Health System', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Henderson', 'role': 'CONTACT'}], 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'centralContacts': [{'name': 'Ann Colasurdo', 'role': 'CONTACT', 'email': 'ann.colasurdo@heart.rochester.edu', 'phone': '585-275-1054'}, {'name': 'Mary Brown', 'role': 'CONTACT', 'email': 'mary.brown@heart.rochester.edu', 'phone': '585-273-5283'}], 'overallOfficials': [{'name': 'Valentina Kutyifa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Roderick Tung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Valentina Kutyifa', 'investigatorAffiliation': 'University of Rochester'}}}}