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Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing

Study acronym: ACHIEVED LBBAP
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 0 to 1
    • Start date: Aug 2026 to Sep 2026
    • Eligibility criteria expanded, about 25 words
  2. Re-verified, no change to tracked fieldsv4
  3. Enrollment increased: 80 → 110 participants
    • Trial arms changed: 2 → 3
    • Interventions: LBBAP Therapy (Device), LOT-CRT (Device) to ICD (Device), LBBAP Therapy (Device), LOT-CRT (Device), LOT-CRT (Device)
    • Secondary endpoints revised (2)
    v3
  4. Study Status, Contacts/Locationsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
Trial Details
NCT Number NCT07526896
Lead Sponsor Medtronic Cardiac Rhythm and Heart Failure
Conditions
(from sponsor)		 Heart Failure, Systolic Bundle Branch Block, Left
Related terms Heart Failure
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov