R-wave Optimisation in Cardiac Resynchronisation Therapy Study

NCT02080000 | Completed DMC

• 1 other identifier: ROC001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Heart Failure; Cardiac Resynchronisation Therapy; Biventricular Pacemaker; Optimisation

Outcome Measures

Primary Outcomes (1)

• Quality of Life Score

  3 months

Secondary Outcomes (2)

• 6 minute hall walk distance

  3 months

• Left Ventricular End Systolic Volume Index

  3 months

Other Outcomes (2)

• Hospitalisation for any cause

  3 months

• Hospitalisation for Heart Failure

  3 months

Study Arms (2)

Optimised V-V timing delay

EXPERIMENTAL

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

Standard V-V timing delay

ACTIVE COMPARATOR

Standard settings

Other: Standard V-V timing settings

Interventions

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

Optimised V-V timing delay

Standard V-V timing settings OTHER

Standard V-V timing delay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

GB (1)