Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ventricular Tachycardia (VT), Ventricular Fibrillation. 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 →
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Overview
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is: • Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.
Primary outcome measures
- R-wave amplitude of LBB EGM [Time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment]
Secondary outcome measures (1)
- EGM morphology-LVAT [Time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment]
Eligibility criteria
Inclusion criteria
- Patients aged >=18 yrs.
- Patients indicated for ICD or CRT-D (primary or secondary prevention)
- Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP
- Patients' EGM can be digitally recorded
- Patients are willing to participate in the study and provide signed informed consent
Exclusion criteria
- Patients received CIED upgrade or replacement with old pacing leads
- Patients are pregnant
- Patients participate in another study that will confound this study
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
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
- Shanghai Tongren Hospital — Shanghai
Publications
- Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec. PMID 36589004
Identifiers
NCT: NCT06745778 · LBBP-ICD study