BBAP With CS Mapping Guidance

NCT07531368 | Not Yet Recruiting

• 1 other identifier: BBAPCSMAPPING2026
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Title Efficacy and Safety of Coronary Sinus-Based Left Atrial Mapping for Guiding Atrial Lead Implantation Targeting Bachmann Bundle Capture in Cardiac Resynchronization Therapy Research Objectives This study intends to use a 10-pole coronary sinus (CS) catheter to map left atrial activation time, assist in identifying the Bachmann bundle (BB) region, and further guide Bachmann bundle atrial pacing (BBAP) lead implantation. The anatomical relationship between the lead and the Bachmann bundle will be displayed by postoperative computed tomographic angiography (CTA), thereby verifying the efficacy and safety of this method in guiding BBAP surgical operations. Study Endpoints Primary Endpoint

• Technical success rate Key Secondary Endpoints
• Procedure time② Radiation dose③ Number of attempts for atrial lead screw-in during the operation: cumulative number of atrial lead implantation attempts during the operation④ Lead repositioning/reoperation rate⑤ Changes in electrical parameters (pacing threshold, lead impedance, intracardiac sensing) of the atrial lead at immediate postoperative, 1-month, 3-month, 6-month, 9-month, and 12-month follow-up⑥ Comparison of the effects of BBAP and right atrial appendage pacing (RAAP) on acute intraoperative hemodynamics⑦ Comparison of the differences in atrial high-rate (AHR) response in pacemaker programming data between BBAP and RAAP during 1-month, 3-month, 6-month, 9-month, and 12-month follow-up Safety Endpoints
• Major safety endpoint: Composite of severe complications② Minor safety endpoint: Incidence of specific adverse events Exploratory Endpoints Health economics, electrophysiological indicators Secondary Efficacy Endpoints To be further clarified according to the study design and clinical data collection. Revisions Summary Full expansion of all abbreviations on first occurrence CS = coronary sinus BB = Bachmann bundle BBAP = Bachmann bundle atrial pacing CTA = computed tomographic angiography RAAP = right atrial appendage pacing AHR = atrial high-rate Minor wording \& clarity improvements Specified "pacing threshold, lead impedance, intracardiac sensing" for clearer electrical parameter description Spelling/typo check No spelling errors, typos, or grammatical issues identified in the original text Consistent terminology maintained throughout

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Technical success rate

  Endpoint name: Success rate of BBAP lead implantation Definition: The proportion of subjects in the study group (guided by 10-pole mapping LAAT) or control group (Lustgarten standard group) whose electrode lead tip reaches the Bachmann bundle region confirmed by postoperative computed tomographic angiography (CTA). Time Frame: From the date of BBAP lead implantation until the date of postoperative computed tomographic angiography (CTA) confirmation before discharge, assessed on Day 5-7 postoperatively Unit of Measure: Percentage (%) Calculation Method: Success rate of BBAP lead implantation = (Number of subjects in the group with lead tip confirmed by CTA to reach the Bachmann bundle region / Number of subjects randomized to the corresponding group) × 100%

  Day 1 after the BBAP procedure (From the date of BBAP lead implantation until the date of postoperative computed tomographic angiography (CTA) confirmation before discharge, assessed on Day 1 postoperatively)

Secondary Outcomes (1)

• Secondary Outcome Measure

  the day of the procedure

Study Arms (2)

CS mapping guidance

EXPERIMENTAL

Device: CS mapping guidance

ECG guidance

ACTIVE COMPARATOR

Device: ECG guidance

Interventions

ECG guidance DEVICE

in the control group, the implantation site meeting the Lustgarten standard is selected

ECG guidance

CS mapping guidance DEVICE

Selection of the optimal target site for atrial lead: In the 10-pole guided group, the electrode pair position with the lowest threshold + shortest LAAT time is selected as the lead implantation target;

CS mapping guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1 Sinus rhythm
• Left ventricular ejection fraction (LVEF) ≤ 35%, QRS duration ≥ 150 ms; or 130 ms \< QRS duration \< 150 ms with left bundle branch block (LBBB) morphology
• LVEF ≤ 40% with expected ventricular pacing \> 20%
• New York Heart Association (NYHA) class II, III, or ambulatory IV symptoms
• After at least 3 months of guideline-directed medical therapy (GDMT) optimization
• Age ≥ 18 years
• Signed informed consent form, good compliance, and ability to complete study follow-up

You may not qualify if:

• Prior implantation of CRT/ICD/pacemaker: Previous implantation of any cardiac implantable electronic device (CIED), except for patients in Group C requiring device replacement/upgrade
• Non-compliance with GDMT requirements: Failure to receive or inability to tolerate optimized medical therapy
• Inappropriate QRS duration: QRS \< 130 ms (Groups A and C)
• Excessive improvement in LVEF: Recent (within 3 months) LVEF \> 40% with clear evidence of normalized cardiac function
• Severe valvular heart disease: Severe aortic stenosis/regurgitation, mitral stenosis requiring surgical or interventional treatment
• Recent cardiovascular events: Acute myocardial infarction, stroke/transient ischemic attack (TIA) within 3 months before enrollment; coronary revascularization (PCI or CABG) within 6 months before enrollment
• Unstable angina pectoris: Canadian Cardiovascular Society (CCS) class III-IV
• Severe arrhythmias: History of sustained ventricular tachycardia or ventricular fibrillation (without ICD protection)
• Types of cardiomyopathy: Hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy (ARVC), and other specific etiologies not suitable for CRT
• Severe renal insufficiency: Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m² or uncontrolled renal failure
• Severe liver dysfunction: Child-Pugh class C
• Active infection: Including sepsis, infective endocarditis, etc.
• Malignant tumor: Advanced malignant tumor with expected survival \< 12 months
• Pregnancy or lactation: Positive pregnancy test in women of childbearing age or planned pregnancy
• Cognitive impairment: Inability to provide informed consent or follow the study protocol

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (1)

• (1) Gerra, L.; Bonini, N.; Mei, D. A.; Imberti, J. F.; Vitolo, M.; Bucci, T.; Boriani, G.; Lip, G. Y. H. Cardiac Resynchronization Therapy (CRT) Nonresponders in the Contemporary Era: A State-of-the-Art Review. Heart Rhythm 2025, 22 (1), 159-169. https://doi.org/10.1016/j.hrthm.2024.05.057. (2) Whinnett, Z.; Naraen, A.; Vijayaraman, P.; Cleland, J. G. F.; Keene, D. Physiological Pacing: Mechanisms, Clinical Indications, and Perspectives. Eur. Heart J. 2025, 46 (35), 3407-3419. https://doi.org/10.1093/eurheartj/ehaf440. (3) Boriani, G.; Padeletti, L. Management of Atrial Fibrillation in Bradyarrhythmias. Nat. Rev. Cardiol. 2015, 12 (6), 337-349. https://doi.org/10.1038/nrcardio.2015.30. (4) M, S.; S, Y.; D, S.; J, S.; D, B.; P, K.; S, C.; C, N. Electrogram-Guided Bachmann Bundle Area Pacing to Correct Interatrial Block: Initial Experience, Safety, and Feasibility. Heart Rhythm 2025, 22 (4). https://doi.org/10.1016/j.hrthm.2024.08.024. (5) Subramanian, M.; Yalagudri, S.; Saggu, D. K.; Dillikar, M.; Singh, J.; Bootla, D.; Korabathina, R.; Chennapragda, S.; Narasimhan, C. Accelerated Bachmann Bundle Area Pacing for Atrial Resynchronization in Patients with Non-Obstructive Hypertrophic Cardiomyopathy and Heart Failure with Preserved Ejection Fraction: A Randomized Crossover Trial. Heart Rhythm 2025, 22 (11), 2757-2765. https://doi.org/10.1016/j.hrthm.2025.07.028. (6) Lustgarten, D. L.; Habel, N.; Sánchez-Quintana, D.; Winget, J.; Correa de Sa, D.; Lobel, R.; Thompson, N.; Infeld, M.; Meyer, M. Bachmann Bundle Pacing. Heart Rhythm 2024, 21 (9), 1711-1717. https://doi.org/10.1016/j.hrthm.2024.03.1786. (7) Tretter, J. T.; Ponnusamy, S. S.; Vijayaraman, P.; Cook, A. C.; Sánchez-Quintana, D.; Anderson, R. H.; Ben-Haim, S. The Anatomy of Atrial Conduction: A Review of Anatomic Landmarks Integrated with Computed Tomographic Virtual Dissection to Provide a Road Map for Right Atrial Pacing. Heart Rhythm 2026, 23 (1), 131-142. https://doi.org/10.1016/j.hrthm.2025.09.032. (8) Infel

  BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

ziqing yu, PhD

CONTACT

64041990; yu.ziqing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share