Reprogramming to Prevent Progressive Pacemaker-induced Remodelling (PPPR)

U

University of Leeds

Status

Completed

Conditions

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

Treatments

Device: Personalised programming

Study type

Interventional

Funder types

Other

Identifiers

NCT03627585
ICA-CDRF-2016-02-055

Details and patient eligibility

About

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.

Full 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.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

91 participants in 2 patient groups

Usual Care
No Intervention group
Description:
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
Personalised programming
Active Comparator group
Description:
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.
Treatment:
Device: Personalised programming

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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