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

Inclusion Criteria9

  • Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (\>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:
  • EF reduced by \>5% of increase in LVESV by 10ml since implant
  • NT-proBNP \>250ng/L in sinus rhythm
  • NT-proBNP \> 750 Ng/L if AF
  • Left atrial volume index \> 30ml/m2
  • Regular loop diuretics prescribed
  • Decline in daily patient activity by \>1 hour per day since implant
  • Decrease in device measured thoracic impedance
  • Patient reported decline in functional class or exercise tolerance

Exclusion Criteria3

  • Those unable to provide informed consent
  • Patients under age 18
  • Pregnant women

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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