Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-09 @ 5:32 AM
Study NCT ID:
NCT06620705
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006327', 'term': 'Heart Block'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}], 'ancestors': [{'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient will be blinded to the treatment allocation. The assessor of the ECG endpoints and echocardiographic endpoints will be blinded to the treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized patient and assessor blinded non-inferiority cross-over trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular end-systolic volume (LVESV) change', 'timeFrame': '6 months', 'description': 'Left ventricular end-systolic volume change measured by echocardiography'}], 'secondaryOutcomes': [{'measure': 'Change in New York Heart Association functional class', 'timeFrame': '6 months', 'description': 'Change in New York Heart Association functional class (NYHA)'}, {'measure': 'Change in Minnesota living with heart failure questionnaire', 'timeFrame': '6 months', 'description': 'The Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered disease-specific questionnaire for patients with heart failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of heart failure on quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst quality of life).'}, {'measure': 'Change in 6-minute walking distance', 'timeFrame': '6 months', 'description': 'Change in 6-minute walking distance'}, {'measure': 'Change in QRS duration', 'timeFrame': '6 months', 'description': 'Change in QRS duration on the 12-lead ECG'}, {'measure': 'Change in vectorcardiographic QRS area', 'timeFrame': '6 months', 'description': 'Change in vectorcardiographic QRS area on the vectorcardiogram reconstructed from a regular 12-lead ECG'}, {'measure': 'Change in left ventricular function', 'timeFrame': '6 months', 'description': 'Change in left ventricular function ejection fraction and global longitudinal strain on echocardiography'}, {'measure': 'Change in NT-proBNP', 'timeFrame': '6 months', 'description': 'Change in NT-proBNP as a heart failure biomarker'}, {'measure': 'Complications', 'timeFrame': '6 months', 'description': 'Complications related to device and leads'}, {'measure': 'Lead pacing thresholds', 'timeFrame': '6 months', 'description': 'Lead pacing thresholds, expressed as volts at pulse width (e.g. 0.4 V @ 0.4 ms). A lower pacing threshold is better.'}, {'measure': 'Costs', 'timeFrame': '6 months', 'description': 'Costs related to the device and leads'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pacing', 'cardiac resynchronization therapy', 'left bundle branch area pacing', 'conduction system pacing', 'heart failure', 'heart block'], 'conditions': ['Heart Failure', 'Block, Heart', 'Pacing-Induced Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.', 'detailedDescription': 'Rationale: Patients with atrial fibrillation (AF) and left ventricular (LV) dysfunction may require ventricular pacing because of bradycardia, AV junction ablation, or for cardiac resynchronization therapy. Right ventricular (RV) pacing is associated with the risk of adverse LV remodelling and heart failure, in particular in those with pre-existing LV dysfunction. Both LBBAP and biventricular pacing can prevent LV dyssynchrony. It is unknown which pacing mode best prevents or reverses LV adverse remodelling in patients with AF who require ventricular pacing or CRT.\n\nPrimary objectives:\n\n1. To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction.\n\n Secondary objectives:\n2. To compare change in quality of life, New York Heart Association functional class, 6-minute walking distance, QRS duration, vectorcardiographic QRS area, left ventricular ejection fraction (LVEF), global longitudinal strain and NT-proBNP between LBBAP and biventricular pacing in patients with AF and LV dysfunction.\n\nStudy design: Randomized patient and assessor blinded non-inferiority cross-over trial.\n\nStudy population: Patients with permanent AF and LVEF \\< 50% who require ventricular pacing because of bradycardia, AV junction ablation, or CRT.\n\nIntervention: Patients will be randomized according to a crossover design to first 6 months of LBBAP and then 6 months of biventricular pacing, or vice versa.\n\nAfter finishing the randomization phase of the study at 12 months, patients will be followed according to routine clinical practice. Clinical follow-up, an ECG, device interrogation and echocardiography will be performed at 36 months (2 years after finishing the randomization phase) in all patients.\n\nMain study parameters/endpoints: New York Heart Association (NYHA) functional class, Minnesota Living with Heart Failure Questionnaire (MLHFQ), 6-minute walking distance, ECG (vectorcardiographic QRS area, QRS duration), echocardiography (LVESV, LVEF, global longitudinal strain), NT-proBNP, lead and device performance (sensing, pacing, expected battery life), complications and costs will be evaluated for each pacing mode.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: For the purpose of this randomized controlled trial, patients will also receive a LBBAP lead. The additional risk of serious adverse events is \\~1.5% (lead dislodgement 1.1%, 0.4% acute coronary syndrome \\[all managed conservatively without further sequelae in prior studies\\]).(1) Patients who participate in the trial will have 3 extra follow-up visits, 4 extra questionnaires, 3 extra ECGs, 3 extra device interrogations, 3 extra echocardiograms and 4 extra blood samples (5 mL each).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Adults ≥18 years with permanent AF and LVEF \\< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.\n* Expected percentage of ventricular pacing \\> 40%\n* ≥ 3 months of heart failure medication optimization\n\nOf note, patients who already have a device, but require an upgrade to a CRT device, can also be included\n\nEXCLUSION CRITERIA\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Age \\< 18 years\n* Pregnancy or active pregnancy wish\n* Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus\n* Recent valve intervention/surgery or acute myocardial infarction (\\< 6 months)\n* NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant'}, 'identificationModule': {'nctId': 'NCT06620705', 'briefTitle': 'Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction', 'orgStudyIdInfo': {'id': 'NL84372.058.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Left bundle branch area pacing', 'description': '6 months of left bundle branch area pacing.', 'interventionNames': ['Device: Left bundle branch area pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biventricular pacing', 'description': '6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus.', 'interventionNames': ['Device: Biventricular pacing']}], 'interventions': [{'name': 'Left bundle branch area pacing', 'type': 'DEVICE', 'otherNames': ['Conduction system pacing', 'Cardiac resynchronization therapy'], 'description': 'Pacing of the left bundle branch area using a transvenous pacemaker lead', 'armGroupLabels': ['Left bundle branch area pacing']}, {'name': 'Biventricular pacing', 'type': 'DEVICE', 'otherNames': ['Cardiac resynchronization therapy'], 'description': 'Pacing of the right and left ventricle using transvenous pacemaker leads', 'armGroupLabels': ['Biventricular pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8200', 'city': 'Aarhus N', 'state': 'Aarhus N', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jens Kristensen, MD, PhD', 'role': 'CONTACT', 'email': 'jens.kristensen@auh.rm.dk', 'phone': '+45 7845 0000'}, {'name': 'Mads B Kronborg, MD, PhD', 'role': 'CONTACT'}, {'name': 'Jens C Nielsen, MD, PhD', 'role': 'CONTACT'}, {'name': 'Jens Kristensen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2300 RC', 'city': 'Leiden', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sebastiaan RD Piers, MD, PhD', 'role': 'CONTACT', 'email': 's.r.d.piers@lumc.nl', 'phone': '0031715262020'}, {'name': 'Sebastiaan RD Piers, MD, PhD', 'role': 'CONTACT'}, {'name': 'Katja Zeppenfeld, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'centralContacts': [{'name': 'Sebastiaan RD Piers, MD, PhD', 'role': 'CONTACT', 'email': 's.r.d.piers@lumc.nl', 'phone': '+31715262020'}], 'overallOfficials': [{'name': 'Sebastiaan Piers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center, Leiden, the Netherlands'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After completion of the study and publication, the data will be shared with other researchers whenever reasonable and of potential benefit for patients.', 'ipdSharing': 'YES', 'description': 'The data will be shared with other researchers whenever reasonable and of potential benefit for patients.', 'accessCriteria': 'Whenever reasonable and of potential benefit for patients.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'srdpiers', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'srdpiers', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}