R-wave Optimisation in Cardiac Resynchronisation Therapy Study

Heart Failure, Systolic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080000
• Other study ID #: ROC001
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: April 27, 2017
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Other:
• Optimisation of V-V timing using R wave on surface ECG

• Standard V-V timing settings

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalisation for any cause		3 months
Other	Hospitalisation for Heart Failure		3 months
Primary	Quality of Life Score		3 months
Secondary	6 minute hall walk distance		3 months
Secondary	Left Ventricular End Systolic Volume Index		3 months