NCT06052475

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Pacing-Induced Cardiomyopathy
• Heart Failure

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-09-25
• Primary completion: 2026-05-01
• Completion: 2026-08-31
• First posted: 2023-09-25
• Last updated: 2024-09-19

Locations

12 sites across 1 country: United Kingdom