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BBAP With CS Mapping Guidance

NCT07531368 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

DEVICE

CS mapping guidance

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;

DEVICE

ECG guidance

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

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531368 on ClinicalTrials.gov