Clinical Trial

Pacing in Heart Failure With Preserved LVEF

Study acronym: MAPPLE
Unknown
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Record status
This record was last updated July 18, 2024 (before its estimated March 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes. The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography. All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order: Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP
Protocol Amendment History 1 change
critical Trial status changed: Enrolling by Invitation → Unknown 2026-08-02
Trial Details
NCT Number NCT03215849
Lead Sponsor Cardiff and Vale University Health Board
Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust, Cardiff Metropolitan University
Conditions Heart Failure
Enrollment 10 participants
Start Date 2023-07-20
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-18