R-wave Optimisation in Cardiac Resynchronisation Therapy Study

Not Applicable

Completed

• Conditions: Heart Failure, Systolic
• Interventions: Other: Standard V-V timing settings; Other: Optimisation of V-V timing using R wave on surface ECG

• Registration Number: NCT02080000
• Lead Sponsor: The Royal Bournemouth Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard V-V timing delay	Standard V-V timing settings	Standard settings
Optimised V-V timing delay	Optimisation of V-V timing using R wave on surface ECG	V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG

Primary Outcome Measures

Name	Time	Method
Quality of Life Score	3 months

Secondary Outcome Measures

Name	Time	Method
Left Ventricular End Systolic Volume Index	3 months
6 minute hall walk distance	3 months

Trial Locations

Locations (1)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, Dorset, United Kingdom