Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

Not Applicable

Completed

• Conditions: Heart Failure, Systolic; Left Ventricular Failure; Pacemaker; Complication, Mechanical; Left Ventricular Dysfunction
• Interventions: Device: Personalised programming

• Registration Number: NCT03627585
• Lead Sponsor: University of Leeds

Brief Summary

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.

This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

Detailed Description

Patients (n=70) with long-term (\>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Primary Completion: 2019-01-06
• Study Completion: 2019-08-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
• Willing and able to give informed consent for the intervention

Exclusion Criteria

• Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
• Patients with complete heart block and no reprogramming options

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalised programming	Personalised programming	Patient will have tailored pacemaker programming based on echocardiographic findings, blood results, and symptoms in an attempt to minimise right ventricular pacing and extend battery longevity.

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	6 months	Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Measures	6 months	EQ-5D, Minnesota living with Heart Failure Questionnaire
Battery Longevity	6 months	Impedance
LV remodelling parameters	6 months	left ventricular end diastolic and systolic volumes

Trial Locations

Locations (2)

Harrogate District Foundation Trust; 🇬🇧 Harrogate, United Kingdom

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom