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Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy

Study acronym: LeCaRT
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 23, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Sep 1, 2023 to Sep 30, 2025v3 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 9 to 11
    • Study completion date: Sep 1, 2024 to Sep 30, 2028
    • Study arms: 4 to 2
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 2 words
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 9
    • Primary completion date: Aug 1, 2023 to Sep 1, 2023
    • Study completion date: Aug 1, 2024 to Sep 1, 2024
    • Start date changed from estimate of Aug 1, 2022 to Sep 1, 2022
    • Secondary endpoints revised (5)
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yield to at least similar clinical benefits and outcomes when compare to biventricular pacing.
Trial Details
NCT Number NCT05365568
Lead Sponsor AZ Sint-Jan AV
Conditions
(from sponsor)
Heart Failure with Reduced Ejection Fraction
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov