NCT03627585

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Ventricular Dysfunction
• Heart Failure, Systolic
• Left Ventricular Failure
• Pacemaker; Complication, Mechanical

Interventions

Type	Name	Description
DEVICE	Personalised programming	Reprogramming protocol already test in an observation cohort will be utilised which will direct physiologists to consider pacemaker mode, base rate, utilisation of rate response, hysteresis, sleep and rest rates as well as lead outputs.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-01-06
• Completion: 2019-08-06
• First posted: 2018-08-13
• Last updated: 2019-09-26

Locations

2 sites across 1 country: United Kingdom