R-wave Optimisation in Cardiac Resynchronisation Therapy Study

The Royal Bournemouth Hospital

Status: Completed

Conditions: Heart Failure, Systolic

Treatments: Other: Standard V-V timing settings; Other: Optimisation of V-V timing using R wave on surface ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT02080000

ROC001

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups

Optimised V-V timing delay

Experimental group

Description:

V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG

Treatment:

Other: Optimisation of V-V timing using R wave on surface ECG

Standard V-V timing delay

Active Comparator group

Description:

Standard settings

Treatment:

Other: Standard V-V timing settings