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R-wave Optimisation in Cardiac Resynchronisation Therapy Study

Primary Purpose

Heart Failure, Systolic

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optimisation of V-V timing using R wave on surface ECG
Standard V-V timing settings
Sponsored by
The Royal Bournemouth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Heart Failure, Cardiac Resynchronisation Therapy, Biventricular Pacemaker, Optimisation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Bournemouth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Optimised V-V timing delay

Standard V-V timing delay

Arm Description

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

Standard settings

Outcomes

Primary Outcome Measures

Quality of Life Score

Secondary Outcome Measures

6 minute hall walk distance
Left Ventricular End Systolic Volume Index

Full Information

First Posted
March 4, 2014
Last Updated
April 27, 2017
Sponsor
The Royal Bournemouth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02080000
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Bournemouth Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
Heart Failure, Cardiac Resynchronisation Therapy, Biventricular Pacemaker, Optimisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimised V-V timing delay
Arm Type
Experimental
Arm Description
V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG
Arm Title
Standard V-V timing delay
Arm Type
Active Comparator
Arm Description
Standard settings
Intervention Type
Other
Intervention Name(s)
Optimisation of V-V timing using R wave on surface ECG
Intervention Type
Other
Intervention Name(s)
Standard V-V timing settings
Primary Outcome Measure Information:
Title
Quality of Life Score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
6 minute hall walk distance
Time Frame
3 months
Title
Left Ventricular End Systolic Volume Index
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Hospitalisation for any cause
Time Frame
3 months
Title
Hospitalisation for Heart Failure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

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R-wave Optimisation in Cardiac Resynchronisation Therapy Study

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