The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity. This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.
Patients (n=70) with long-term (\>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Reprogramming protocol already test in an observation cohort will be utilised which will direct physiologists to consider pacemaker mode, base rate, utilisation of rate response, hysteresis, sleep and rest rates as well as lead outputs.
Harrogate District Foundation Trust
Harrogate, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Left ventricular ejection fraction
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
Time frame: 6 months
LV remodelling parameters
left ventricular end diastolic and systolic volumes
Time frame: 6 months
Quality of Life Measures
EQ-5D, Minnesota living with Heart Failure Questionnaire
Time frame: 6 months
Battery Longevity
Impedance
Time frame: 6 months
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