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Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Enrollment closed, study ongoing Show 5 more changesShow less
    • Study completion pushed from Jul 31, 2026 to Oct 31, 2026
    • Primary completion date changed from estimate of Jul 31, 2026 to Aug 18, 2026
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
  2. Notable Primary completion date: Dec 31, 2025 to Jul 31, 2026
    • Study completion date: Jun 30, 2026 to Jul 31, 2026
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 28, 2025 to Feb 26, 2025
    • Publications: details revised at 1 of 1 entry
    v3
  4. Notable Start date: Dec 31, 2024 to Feb 28, 2025v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06745778
Lead Sponsor Medtronic Cardiac Rhythm and Heart Failure
Conditions
(from sponsor)
Ventricular Tachycardia (VT), Ventricular Fibrillation
Related terms Tachycardia, Ventricular, Ventricular Fibrillation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov