Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

NCT03627585 | Completed

• 1 other identifier: ICA-CDRF-2016-02-055
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Left Ventricular Dysfunction; Heart Failure, Systolic; Left Ventricular Failure; Pacemaker; Complication, Mechanical

Keywords

pacemaker; heart failure; left ventricular dysfunction; bradycardia; remodelling

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction

  Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.

  6 months

Secondary Outcomes (3)

• LV remodelling parameters

  6 months

• Quality of Life Measures

  6 months

• Battery Longevity

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

Patients received echocardiogram but no pacemaker reprogramming or personalisation.

Personalised programming

ACTIVE COMPARATOR

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

Interventions

Personalised programming DEVICE

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.

Personalised programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
• Willing and able to give informed consent for the intervention

You may not qualify if:

• Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
• Patients with complete heart block and no reprogramming options

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (2)

Harrogate District Foundation Trust

Harrogate, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34898655 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Heart Failure, Systolic; Heart Failure; Bradycardia

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus Witte, MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Cardiology

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 13, 2018
• Study Start: August 1, 2017
• Primary Completion: January 6, 2019
• Study Completion: August 6, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

GB (2)