Bolt CSP-M Holter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Heart Failure, Bradycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intracardiac Electrical Characteristics of LBBAP
Overview
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.
Detailed description
Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.
During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Intracardiac electrical characteristics in different pacing outputs. [Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment]
Secondary outcome measures (2)
- Intracardiac electrical characteristics under different body position. [Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment]
- The correlation between LBB capture status and LBBAP EGM characteristics [Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment]
Eligibility criteria
Inclusion criteria
- Patients aged >=18 years
- Patients who are willing to provide Informed Consent
- Patients who have received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month)
- Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
- Implanted device can provide at least 3-channel real-time intracardiac electrogram
Exclusion criteria
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in clinical trial(s) which would impact study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 2 centers
- Shanghai Chest Hospital — Shanghai
- Zhejiang Greentown Cardiovascular Hospital — Hangzhou
Publications
- Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22. PMID 29173611
- Chen X, Qian Z, Zou F, Wang Y, Zhang X, Qiu Y, Hou X, Zhou X, Vijayaraman P, Zou J. Differentiating left bundle branch pacing and left ventricular septal pacing: An algorithm based on intracardiac electrophysiology. J Cardiovasc Electrophysiol. 2022 Mar;33(3):448-457. doi: 10.1111/jce.15350. Epub 2022 Jan 12. PMID 34978368
- Zhou Y, Wang J, Wei Y, Zhang W, Yang Y, Rui S, Ju C. Left ventricular septal pacing versus left bundle branch pacing in the treatment of atrioventricular block. Ann Noninvasive Electrocardiol. 2022 May;27(3):e12944. doi: 10.1111/anec.12944. Epub 2022 Mar 10. PMID 35267228
- Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28. PMID 33933414
Identifiers
NCT: NCT06540521 · MDT24030