R-wave Optimisation in Cardiac Resynchronisation Therapy Study

NCT ID: NCT02080000

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-03-31

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.

Conditions

Heart Failure, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Standard V-V timing delay

Standard settings

Group Type: ACTIVE_COMPARATOR

Standard V-V timing settings

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

Standard V-V timing settings

Intervention Type: OTHER

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Bournemouth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

ROC001

Identifier Type: -

Identifier Source: org_study_id