R-wave Optimisation in Cardiac Resynchronisation Therapy Study

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Systolic
• Intervention / Treatment: Other: Optimisation of V-V timing using R wave on surface ECG; Other: Standard V-V timing settings

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimised V-V timing delay; 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
Active Comparator: Standard V-V timing delay; Standard settings	Other: Standard V-V timing settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Score	3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Hospitalisation for any cause	3 months
Hospitalisation for Heart Failure	3 months

Collaborators and Investigators

• Sponsor: The Royal Bournemouth Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronisation Therapy; Optimisation; Biventricular Pacemaker
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: ROC001