Skip to main content
OpenTrials
Completed

NCT Number: NCT03627585

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Left Ventricular Dysfunction Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic Left Ventricular Failure Pacemaker; Complication, Mechanical Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harrogate District Foundation Trust, Harrogate, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalised programming

Device

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.

Primary outcomes

  1. Left ventricular ejection fraction

    Time frame: 6 months

    Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.

Secondary outcomes

  1. LV remodelling parameters

    Time frame: 6 months

    left ventricular end diastolic and systolic volumes

  2. Quality of Life Measures

    Time frame: 6 months

    EQ-5D, Minnesota living with Heart Failure Questionnaire

  3. Battery Longevity

    Time frame: 6 months

    Impedance

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Acronym: PPPR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2018
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.