Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study.
Shunmuga Sundaram Ponnusamy, Vadivelu Ramalingam, Vithiya Ganesan...
https://pubmed.ncbi.nlm.nih.gov/36589004/Actively Recruiting
Led by Medtronic Cardiac Rhythm and Heart Failure · Updated on 2026-05-08
50
Participants Needed
2
Research Sites
N/A
Total Duration
This observational study focuses on patients with implanted ICD or CRT-D devices who have recently received left bundle branch pacing LBBP leads. It aims to investigate whether the LBBP lead can provide accurate, stable, and valid intracardiac electrograms EGMs for sensing and detection of ventricular tachyarrhythmia events. The study particularly examines changes in the LBB EGM during daily activities and overdrive pacing around the time of implantation and over a six-month period afterward. Participants are patients who have recently undergone ICD or CRT-D implantation with LBBP leads. Intracardiac EGMs will be recorded using ambulatory Holter monitors during resting and walking conditions as well as during overdrive pacing. These recordings will occur at the time of peri-implantation and at follow-up visits up to six months after enrollment. During the study, participants will have their EGMs collected non-invasively by Holter monitoring at enrollment, three months, and six months after enrollment. Researchers will measure R-wave amplitude of the LBB EGM and assess EGM morphology and left ventricular activation time LVAT. The study involves no treatment changes but focuses on data collection and analysis. Participation lasts for six months, during which patients cardiac electrical signals are monitored to evaluate the LBBP leads sensing capabilities.
CONDITIONS
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
S
Simon Cao, Ph.D
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Medtronic Cardiac Rhythm and Heart Failure
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants wear an ambulatory Holter monitor to record intracardiac electrograms during rest, walking, and overdrive pacing at implantation and follow-ups.
Visits at enrollment, 3 months, and 6 months
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Shunmuga Sundaram Ponnusamy, Vadivelu Ramalingam, Vithiya Ganesan...
https://pubmed.ncbi.nlm.nih.gov/36589004/Medtronic Cardiac Rhythm and Heart Failure
Lead Sponsor