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Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

NCT06052475 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2024-09-19

No results posted yet for this study

Summary

Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.

However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.

This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.

In this crossover trial, participants will be upgraded to a physiological pacing strategy.

After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).

They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.

Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.

The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.

Conditions

Interventions

DEVICE

Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)

The approach for physiological pacing upgrade will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.

DEVICE

Continued RV Pacing (Right Ventricular Pacing)

Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Daniel Keene, PhD · Imperial College London

  • Nandita Kaza, MRCP · Imperial College London

  • Matthew Shun-Shin, PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-05-01
Completion
2026-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT06052475 on ClinicalTrials.gov