An interventional study of Personalised programming in Left Ventricular Dysfunction, Heart Failure, Systolic and Left Ventricular Failure, sponsored by University of Leeds. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of Leeds · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 91 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
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
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
Time frame: 6 months
LV remodelling parameters
left ventricular end diastolic and systolic volumes
Time frame: 6 months
Quality of Life Measures
EQ-5D, Minnesota living with Heart Failure Questionnaire
Time frame: 6 months
Battery Longevity
Impedance
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Leeds