MedTrace Logo

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

NCT03627585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-09-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Principal Investigators

  • Klaus Witte, MD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-01-06
Completion
2019-08-06

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03627585 on ClinicalTrials.gov