Clinical trial NCT02080000: R-wave Optimisation in Cardiac Resynchronisation Therapy Study
Official title: Use of the R-wave to Optimise VV Delay in Heart Failure Patients Treated With Cardiac Resynchronisation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: Heart Failure
Cardiac Resynchronisation Therapy
Biventricular Pacemaker
Optimisation
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Quality of Life Score
timeFrame: 3 months
Secondary outcomes:
measure: 6 minute hall walk distance
timeFrame: 3 months
measure: Left Ventricular End Systolic Volume Index
timeFrame: 3 months
Other outcomes:
measure: Hospitalisation for any cause
timeFrame: 3 months
measure: Hospitalisation for Heart Failure
timeFrame: 3 months
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
References: