Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized ā¦ (NCT06318130) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized Clinical Trial
Singapore210 participantsStarted 2023-01-01
Plain-language summary
This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Fulfil current indications for pacemaker therapy according to international guideline recommendations:
ā. Symptomatic sinus bradycardia/sinus node dysfunction or AV block requiring pacemaker insertion.
ā. Symptomatic heart failure, left ventricular ejection fraction (LVEF) \<35%, left bundle branch block and QRS duration \>120ms.
ā. Symptomatic heart failure, left ventricular ejection fraction (LVEF) \<35%, right bundle branch block and QRS duration \>150ms.
ā. LVEF \<50% with significant anticipated ventricular pacing requirement of ā„20%.
ā. Age ā„21 years old
ā. Able to provide informed consent
ā. Planned LBBP implantation
Exclusion criteria
ā. Severe tricuspid regurgitation or previous tricuspid valve intervention requiring implantation of left ventricular lead in the coronary sinus.