R-wave Optimisation in Cardiac Resynchronisation Therapy Study

Study Overview
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Brief Summary
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The aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management. More specifically it is to investigate whether using the R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular (RV) pacing improves response to Cardiac Resynchronisation Therapy.

Official Title
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Use of the R-wave to Optimise VV Delay in Heart Failure Patients Treated With Cardiac Resynchronisation Therapy

Conditions
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Heart Failure, Systolic

Intervention / Treatment
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* Other: Optimisation of V-V timing using R wave on surface ECG
* Other: Standard V-V timing settings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The patient must have a biventricular pacemaker in situ, implanted for NYHA Class III / IV heart failure syndrome with impaired systolic function. Implantation indication must have included a left ventricular ejection fraction measured on transthoracic echo of <35% and either a QRS duration of >150ms or a QRS duration of 120 - 149ms with further evidence of dyssynchrony confirmed by echocardiography. Participants must have >95% true biventricular pacing over the 1 month before enrolment and throughout the observation period. The biventricular paced QRS complex morphology in lead V1 of subject's standard 12 lead surface ECG must show an R wave height of < 1mm or <20% of the total QRS deflection with standard LV offset settings applied. The subject's standard 12 lead surface ECG must show a right bundle branch block pattern in lead V1 during LV only pacing. The participant must be willing to comply with the protocol requirements including travelling to the Royal Bournemouth Hospital for the attendances required for the study and intend to have their long term device follow up at the Royal Bournemouth Hospital at the time of enrolment. Provision of informed consent Exclusion criteria Hypertrophic or restrictive cardiomyopathy Suspected acute myocarditis Correctable Valvulopathy An Acute Coronary Syndrome within the last 3 months Recent (within the last 3 months) or scheduled coronary revascularisation Treatment resistant hypertension Severe obstructive lung disease Pregnancy at the time of enrolment or a desire to become pregnant during the study period An inability to walk Reduced life expectancy not associated with cardiovascular disease (less than 1 year) Unable to provide informed consent

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimised V-V timing delay<br>V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG | Other: Optimisation of V-V timing using R wave on surface ECG<br> <br> |
| Active Comparator: Standard V-V timing delay<br>Standard settings | Other: Standard V-V timing settings<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute hall walk distance |  | 3 months | 
| Left Ventricular End Systolic Volume Index |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiac Resynchronisation Therapy, Biventricular Pacemaker, Optimisation