Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:51 AM
Study NCT ID:
NCT07360067
Status:
RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Bachmann Bundle Versus Right Atrial Appendage Pacing: Impact on Atrial Cardiomyopathy Evaluated by Echocardiographic Parameters and Clinical Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012804', 'term': 'Sick Sinus Syndrome'}], 'ancestors': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structural echocardiographic parameters of the left atrium', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'LA Volume Index measured as mL/m\\^2'}, {'measure': 'Functional echocardiographic parameters of the left atrium', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'Reservoir Strain (%), Conduit Strain (%), Contraction Strain (%)'}], 'secondaryOutcomes': [{'measure': 'Structural echocardiographic parameters of the left ventricle', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'LV End-Diastolic Diameter(mm), LV End-Systolic Diameter(mm)'}, {'measure': 'Functional echocardiographic parameters of the left ventricle', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'LV Ejection Fraction (%), Global Longitudinal Strain (%)'}, {'measure': 'Mitral and tricuspid regurgitation volume', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'as mL per beat'}, {'measure': 'Structural echocardiographic parameters of the right atrium', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'RA Volume Index (mL/m\\^2)'}, {'measure': 'Functional echocardiographic parameters of the right atrium', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'RA Reservoir Strain (%), RA Conduit Strain (%), RA Contraction Strain (%)'}, {'measure': 'ECG parameters', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'PR interval (ms), QRS duration (ms), P wave duration (ms), QTC (ms)'}, {'measure': 'Average heart rate', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'bpm'}, {'measure': 'Heart rate distribution', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'percentage (%)'}, {'measure': 'Pacing burden', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'percentage (%)'}, {'measure': 'Atrial fibrillation burden', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'percentage (%)'}, {'measure': 'atrial fibrillation occurrence', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'count'}, {'measure': 'NTproBNP', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'pg/ml'}, {'measure': 'Procedure-related complications', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'count'}, {'measure': 'Pacemaker/Implantable cardioverter defibrillator parameters', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'Threshold (V)'}, {'measure': 'Pacemaker/Implantable cardioverter defibrillator parameters', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'longevity (year)'}, {'measure': 'Cardiac mortality', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'count'}, {'measure': 'All-cause mortality', 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'count'}, {'measure': "Patient's functional status", 'timeFrame': '6 and 12 months after pacemaker implantation', 'description': 'NYHA class I\\~IV'}, {'measure': 'hospitalization due to heart failure', 'timeFrame': '6 and 12 months post-procedure', 'description': 'count'}, {'measure': 're-admission due to any cause', 'timeFrame': '6 and 12 months post-procedure', 'description': 'count'}, {'measure': 'Cerebrovascular event', 'timeFrame': '6 and 12 months post-procedure', 'description': 'count'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bachmann bundle pacing'], 'conditions': ['Sick Sinus Syndrome']}, 'referencesModule': {'references': [{'pmid': '11513442', 'type': 'RESULT', 'citation': "Bailin SJ, Adler S, Giudici M. Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial. J Cardiovasc Electrophysiol. 2001 Aug;12(8):912-7. doi: 10.1046/j.1540-8167.2001.00912.x."}, {'pmid': '35304608', 'type': 'RESULT', 'citation': "Infeld M, Nicoli CD, Meagher S, Tompkins BJ, Wayne S, Irvine B, Betageri O, Habel N, Till S, Lobel J, Meyer M, Lustgarten DL. Clinical impact of Bachmann's bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes. Europace. 2022 Oct 13;24(9):1460-1468. doi: 10.1093/europace/euac029."}, {'pmid': '38552731', 'type': 'RESULT', 'citation': 'Lustgarten DL, Habel N, Sanchez-Quintana D, Winget J, Correa de Sa D, Lobel R, Thompson N, Infeld M, Meyer M. Bachmann bundle pacing. Heart Rhythm. 2024 Sep;21(9):1711-1717. doi: 10.1016/j.hrthm.2024.03.1786. Epub 2024 Mar 27. No abstract available.'}, {'pmid': '31326478', 'type': 'RESULT', 'citation': 'Martens P, Deferm S, Bertrand PB, Verbrugge FH, Ramaekers J, Verhaert D, Dupont M, Vandervoort PM, Mullens W. The Detrimental Effect of RA Pacing on LA Function and Clinical Outcome in Cardiac Resynchronization Therapy. JACC Cardiovasc Imaging. 2020 Apr;13(4):895-906. doi: 10.1016/j.jcmg.2019.04.022. Epub 2019 Jul 17.'}, {'pmid': '11310300', 'type': 'RESULT', 'citation': 'Roithinger FX, Abou-Harb M, Pachinger O, Hintringer F. The effect of the atrial pacing site on the total atrial activation time. Pacing Clin Electrophysiol. 2001 Mar;24(3):316-22. doi: 10.1046/j.1460-9592.2001.00316.x.'}, {'pmid': '12494610', 'type': 'RESULT', 'citation': 'De Sisti A, Leclercq JF, Stiubei M, Fiorello P, Halimi F, Attuel P. P wave duration and morphology predict atrial fibrillation recurrence in patients with sinus node dysfunction and atrial-based pacemaker. Pacing Clin Electrophysiol. 2002 Nov;25(11):1546-54. doi: 10.1046/j.1460-9592.2002.01546.x.'}, {'pmid': '21819434', 'type': 'RESULT', 'citation': 'Elkayam LU, Koehler JL, Sheldon TJ, Glotzer TV, Rosenthal LS, Lamas GA. The influence of atrial and ventricular pacing on the incidence of atrial fibrillation: a meta-analysis. Pacing Clin Electrophysiol. 2011 Dec;34(12):1593-9. doi: 10.1111/j.1540-8159.2011.03192.x. Epub 2011 Aug 7.'}, {'pmid': '25512875', 'type': 'RESULT', 'citation': 'Bradshaw PJ, Stobie P, Knuiman MW, Briffa TG, Hobbs MS. Trends in the incidence and prevalence of cardiac pacemaker insertions in an ageing population. Open Heart. 2014 Dec 10;1(1):e000177. doi: 10.1136/openhrt-2014-000177. eCollection 2014.'}, {'pmid': '29545242', 'type': 'RESULT', 'citation': 'Honarbakhsh S, Hunter L, Chow A, Hunter RJ. Bradyarrhythmias and pacemakers. BMJ. 2018 Mar 15;360:k642. doi: 10.1136/bmj.k642. No abstract available.'}, {'pmid': '30586772', 'type': 'RESULT', 'citation': 'Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2019 Aug 20;140(8):e382-e482. doi: 10.1161/CIR.0000000000000628. Epub 2018 Nov 6. No abstract available. Erratum In: Circulation. 2019 Aug 20;140(8):e506-e508. doi: 10.1161/CIR.0000000000000721.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to evaluate the impact of different atrial pacing sites-Bachmann's bundle pacing versus right atrial appendage pacing-on the development and progression of atrial cardiomyopathy in patients diagnosed with sick sinus syndrome who are undergoing permanent pacemaker implantation.", 'detailedDescription': 'Previous studies have reported that conventional Right Atrial Appendage pacing is associated with delayed atrial activation time. A higher burden of atrial pacing at this site has been linked to an increased incidence of atrial fibrillation and atrial tachycardia. Furthermore, structural and functional deterioration of the atria-specifically Left Atrial dilation and reduced left atrial strain-has been observed in patients with a high percentage of Right Atrial Appendage pacing. These changes are known to accelerate the progression of atrial cardiomyopathy, potentially leading to adverse long-term clinical outcomes.\n\nTo address these limitations, Bachmann Bundle Pacing has emerged as a promising alternative pacing site. The Bachmann bundle is a major atrial myoarchitecture connecting the right and left atria. Pacing at this site is expected to facilitate interatrial conduction, thereby restoring interatrial synchrony and mitigating interatrial block. Prior research indicates that pacing at the Bachmann bundle is associated with a reduced incidence of atrial fibrillation and atrial tachycardia, suggesting distinct benefits regarding atrial electrophysiological outcomes. However, existing studies have primarily focused on electrophysiological parameters, such as arrhythmia incidence. Consequently, the impact of Bachmann Bundle Pacing on atrial structural and functional remodeling remains to be clearly elucidated.\n\nTherefore, this study is designed as a single-center cohort study enrolling a total of 200 subjects (100 prospective and 100 retrospective). We will analyze echocardiographic parameters over a 12-month period following pacemaker implantation. By comprehensively analyzing imaging parameters (left atrial/right atrial strain and volume changes assessed via echocardiography) and clinical outcomes (atrial arrhythmias, heart failure hospitalization, and mortality), this study aims to investigate the differential effects of Bachmann Bundle Pacing versus Right Atrial Appendage pacing on the development and progression of atrial cardiomyopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who presented to Samsung Medical Center, were diagnosed with Sick Sinus Syndrome, and underwent de novo permanent pacemaker or implantable cardioverter-defibrillator implantation based on clinical indications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 19 years or older\n* Patients diagnosed with sick sinus syndrome who are scheduled for de novo implantation of a permanent pacemaker or permanent implantable cardioverter-defibrillator\n* Patients or their legal representatives who voluntarily consent to the access of medical records and study data throughout the entire research period\n\nExclusion Criteria:\n\n* Patients with persistent or permanent AF\n* Patients with a life expectancy of less than one year due to other comorbidities\n* Pregnant or breastfeeding women\n* Patients who refuse active treatment'}, 'identificationModule': {'nctId': 'NCT07360067', 'acronym': 'BRAVE', 'briefTitle': 'Prospective Cohort Study of Bachmann Bundle Versus Right Atrial Appendage Pacing: Impact on Atrial Cardiomyopathy Evaluated by Echocardiographic Parameters and Clinical Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Cohort Study of Bachmann Bundle Versus Right Atrial Appendage Pacing: Impact on Atrial Cardiomyopathy Evaluated by Echocardiographic Parameters and Clinical Outcome', 'orgStudyIdInfo': {'id': 'SMC2025-10-106'}, 'secondaryIdInfos': [{'id': 'KCT0011382', 'type': 'OTHER', 'domain': 'Korea National Institute of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Right Atrial Appendage Pacing', 'description': 'Right Atrial Appendage Pacing', 'interventionNames': ['Procedure: Right Atrial Appendage Pacing']}, {'label': 'Bachmann Bundle Pacing', 'description': 'Bachmann Bundle Pacing', 'interventionNames': ['Procedure: Bachmann Bundle Pacing']}], 'interventions': [{'name': 'Right Atrial Appendage Pacing', 'type': 'PROCEDURE', 'description': 'Atrial lead positioned in the right atrial appendage', 'armGroupLabels': ['Right Atrial Appendage Pacing']}, {'name': 'Bachmann Bundle Pacing', 'type': 'PROCEDURE', 'description': 'Atrial lead positioned in the bachmann bundle branch', 'armGroupLabels': ['Bachmann Bundle Pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kim Ju Won, Clinical assistant professor, Ph.D', 'role': 'CONTACT', 'email': 'abcd186a@naver.com', 'phone': '82+ 2-3410-3419'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kim Ju Won, Clinical assistant professor, Ph.D', 'role': 'CONTACT', 'email': 'abcd186a@naver.com', 'phone': '82+ 10-2079-8154'}, {'name': 'Lee Ju Hee, Clinical Research Nurse, Bachelor', 'role': 'CONTACT', 'email': 'phacyde12@gmail.com', 'phone': '82+ 10-7180-3357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}