Heart Failure, Systolic, Left Ventricular Dysfunction, Left Ventricular Failure, Pacemaker; Complication, Mechanical
Conditions
Keywords
pacemaker, heart failure, left ventricular dysfunction, bradycardia, remodelling
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.
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.
Interventions
DEVICEPersonalised 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.
Sponsors
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction | 6 months | Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed