RecruitingNot ApplicableNCT06052475

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades


Sponsor

Imperial College London

Enrollment

155 participants

Start Date

Sep 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of pacemaker upgrades for people who already have a right-sided pacemaker and are experiencing declining heart function due to the way the pacemaker stimulates the heart. The upgrade options are: a traditional cardiac resynchronization device versus a newer "physiological" pacing method. **You may be eligible if...** - You already have a right ventricular pacemaker - Your heart's pumping function (ejection fraction) is between 35% and 50% - More than 40% of your heartbeats are paced by the device - You are showing signs of worsening heart function since the device was implanted (elevated heart failure markers, fluid retention, reduced activity tolerance) - Your doctor has recommended upgrading your pacemaker **You may NOT be eligible if...** - You are unable to provide informed consent - You are under 18 - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhysiological 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.

DEVICEContinued RV Pacing (Right Ventricular Pacing)

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


Locations(12)

Royal Papworth Hospital

Cambridge, United Kingdom

St. Richard's Hospital - University Hospitals Sussex

Chichester, United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust,

Coventry, United Kingdom

Croydon University Hospital - Croydon Health Services

Croydon, United Kingdom

Glenfield Hospital

Leicester, United Kingdom

Hammersmith Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

St Bartholomew's Hospital - Barts Health NHS Trust

London, United Kingdom

Oxford University Hospitals

Oxford, United Kingdom

University Hospitals Southampton

Southampton, United Kingdom

Great Western Hospitals

Swindon, United Kingdom

Worthing Hospital - University Hospitals Sussex

Worthing, United Kingdom

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NCT06052475


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