Trials / Recruiting
RecruitingNCT06540521
Bolt CSP-M Holter Study
Intracardiac Electrical Characteristics of LBBAP
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (estimated)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention |
Timeline
- Start date
- 2024-08-13
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2024-08-06
- Last updated
- 2025-09-29
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06540521. Inclusion in this directory is not an endorsement.