Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Last updated: September 4, 2024
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Heart Failure

Arrhythmia

Treatment

Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)

Continued RV Pacing (Right Ventricular Pacing)

Clinical Study ID

NCT06052475
23HH8156
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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:

  1. EF reduced by >5% of increase in LVESV by 10ml since implant

  2. NT-proBNP >250ng/L in sinus rhythm

  3. NT-proBNP > 750 Ng/L if AF

  4. Left atrial volume index > 30ml/m2

  5. Regular loop diuretics prescribed

  6. Decline in daily patient activity by >1 hour per day since implant

  7. Decrease in device measured thoracic impedance

  8. Patient reported decline in functional class or exercise tolerance

Exclusion

Exclusion Criteria:

  • Those unable to provide informed consent

  • Patients under age 18

  • Pregnant women

Study Design

Total Participants: 155
Treatment Group(s): 2
Primary Treatment: Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
Phase:
Study Start date:
September 25, 2023
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Royal Papworth Hospital

    Cambridge,
    United Kingdom

    Active - Recruiting

  • St. Richard's Hospital - University Hospitals Sussex

    Chichester,
    United Kingdom

    Active - Recruiting

  • University Hospitals Coventry and Warwickshire NHS Trust,

    Coventry,
    United Kingdom

    Active - Recruiting

  • Croydon University Hospital - Croydon Health Services

    Croydon,
    United Kingdom

    Active - Recruiting

  • Glenfield Hospital

    Leicester,
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital

    London,
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital - Barts Health NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals

    Oxford,
    United Kingdom

    Active - Recruiting

  • University Hospitals Southampton

    Southampton,
    United Kingdom

    Active - Recruiting

  • Great Western Hospitals

    Swindon,
    United Kingdom

    Active - Recruiting

  • Worthing Hospital - University Hospitals Sussex

    Worthing,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.