Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
NCT ID: NCT06052475
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
155 participants
INTERVENTIONAL
2023-09-25
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Physiological Pacing (Conduction System Pacing or Biventricular Pacing)
The approach for physiological pacing 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.
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.
Right Ventricular Pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)
Continued RV Pacing (Right Ventricular Pacing)
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Interventions
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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.
Continued RV Pacing (Right Ventricular Pacing)
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Eligibility Criteria
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Exclusion Criteria
* Patients under age 18
* Pregnant women
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Daniel Keene, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Nandita Kaza, MRCP
Role: STUDY_DIRECTOR
Imperial College London
Matthew Shun-Shin, PhD
Role: STUDY_DIRECTOR
Imperial College London
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Daniel Keene, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23HH8156
Identifier Type: -
Identifier Source: org_study_id
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