Reprogramming to Prevent Progressive Pacemaker-induced Remodelling (PPPR)
|ClinicalTrials.gov Identifier: NCT03627585|
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : September 26, 2019
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||January 6, 2019|
|Actual Study Completion Date :||August 6, 2019|
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.
- Left ventricular ejection fraction [ Time Frame: 6 months ]Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
- LV remodelling parameters [ Time Frame: 6 months ]left ventricular end diastolic and systolic volumes
- Quality of Life Measures [ Time Frame: 6 months ]EQ-5D, Minnesota living with Heart Failure Questionnaire
- Battery Longevity [ Time Frame: 6 months ]Impedance
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627585
|Harrogate District Foundation Trust|
|Harrogate, United Kingdom|
|Leeds Teaching Hospitals NHS Trust|
|Leeds, United Kingdom, LS1 3EX|
|Principal Investigator:||Klaus Witte, MD||University of Leeds|