PPPR: Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

Sponsor

University of Leeds (Other)

Overall Status

Completed

CT.gov ID

NCT03627585

Collaborator

(none)

Enrollment

Locations

Arms

24.1

Actual Duration (Months)

45.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Dysfunction Heart Failure, Systolic Left Ventricular Failure Pacemaker; Complication, Mechanical	Device: Personalised programming	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Jan 6, 2019

Actual Study Completion Date :

Aug 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Patients received echocardiogram but no pacemaker reprogramming or personalisation.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

No Intervention: Usual Care

Patients received echocardiogram but no pacemaker reprogramming or personalisation.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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