Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
NCT ID: NCT03627585
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2017-08-01
2019-08-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Usual Care
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Willing and able to give informed consent for the intervention
Exclusion Criteria
* Patients with complete heart block and no reprogramming options
18 Years
ALL
No
Sponsors
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University of Leeds
OTHER
Responsible Party
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KK Witte
Senior Lecturer in Cardiology
Principal Investigators
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Klaus Witte, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Harrogate District Foundation Trust
Harrogate, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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References
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Paton MF, Gierula J, Lowry JE, Cairns DA, Bose Rosling K, Cole CA, McGinlay M, Straw S, Byrom R, Cubbon RM, Kearney MT, Witte KK. Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial. PLoS One. 2021 Dec 13;16(12):e0259450. doi: 10.1371/journal.pone.0259450. eCollection 2021.
Other Identifiers
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ICA-CDRF-2016-02-055
Identifier Type: -
Identifier Source: org_study_id
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