Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling

Conditions
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Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical

Intervention / Treatment
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* Device: Personalised programming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic right ventricular bradycardia pacemaker implanted for at least 24 months Willing and able to give informed consent for the intervention Exclusion Criteria: Known poor imaging quality patients (details of patients excluded for this reason will be recorded) Patients with complete heart block and no reprogramming options

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Patients received echocardiogram but no pacemaker reprogramming or personalisation. | |
| Active Comparator: Personalised programming<br>Patient will have tailored pacemaker programming based on echocardiographic findings, blood results, and symptoms in an attempt to minimise right ventricular pacing and extend battery longevity. | Device: Personalised programming<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV remodelling parameters | left ventricular end diastolic and systolic volumes | 6 months | 
| Quality of Life Measures | EQ-5D, Minnesota living with Heart Failure Questionnaire | 6 months | 
| Battery Longevity | Impedance | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, heart failure, left ventricular dysfunction, bradycardia, remodelling