Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06052475

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Led by Imperial College London · Updated on 2024-09-19

155

Participants Needed

12

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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 Criteria:

  • Those unable to provide informed consent
  • Patients under age 18
  • Pregnant women
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Royal Papworth Hospital

Cambridge, United Kingdom

Actively Recruiting

2

St. Richard's Hospital - University Hospitals Sussex

Chichester, United Kingdom

Actively Recruiting

3

University Hospitals Coventry and Warwickshire NHS Trust,

Coventry, United Kingdom

Actively Recruiting

4

Croydon University Hospital - Croydon Health Services

Croydon, United Kingdom

Actively Recruiting

5

Glenfield Hospital

Leicester, United Kingdom

Actively Recruiting

6

Hammersmith Hospital

London, United Kingdom

Actively Recruiting

7

King's College Hospital

London, United Kingdom

Actively Recruiting

8

St Bartholomew's Hospital - Barts Health NHS Trust

London, United Kingdom

Actively Recruiting

9

Oxford University Hospitals

Oxford, United Kingdom

Actively Recruiting

10

University Hospitals Southampton

Southampton, United Kingdom

Actively Recruiting

11

Great Western Hospitals

Swindon, United Kingdom

Actively Recruiting

12

Worthing Hospital - University Hospitals Sussex

Worthing, United Kingdom

Actively Recruiting

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Research Team

A

Aya Khalil

CONTACT

N

Nandita Kaza, MRCP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades | DecenTrialz