Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
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1 other identifier
interventional
155
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
September 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedSeptember 19, 2024
September 1, 2024
2.6 years
September 19, 2023
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
From date of baseline, until end of trial follow-up at fourteen months post-baseline
Secondary Outcomes (12)
Left ventricular ejection fraction
From date of baseline, until end of trial follow-up at fourteen months
Left ventricular end systolic volume
From date of baseline, until end of trial follow-up at fourteen months
Minnesota Living with Heart Failure Questionnaire
From date of baseline, until end of trial follow-up at fourteen months
Six-minute walk test
From date of baseline, until end of trial follow-up at fourteen months
Atrial fibrillation
From date of baseline, until end of trial follow-up at fourteen months
- +7 more secondary outcomes
Study Arms (2)
Physiological Pacing (Conduction System Pacing or Biventricular Pacing)
EXPERIMENTALThe 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.
Right Ventricular Pacing
ACTIVE COMPARATORRight ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)
Interventions
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 (apical or septal lead locations as per the implanting physicians' normal practice).
Eligibility Criteria
You may not qualify if:
- Those unable to provide informed consent
- Patients under age 18
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Keene, PhD
Imperial College London
- STUDY DIRECTOR
Nandita Kaza, MRCP
Imperial College London
- STUDY DIRECTOR
Matthew Shun-Shin, PhD
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2023
First Posted
September 25, 2023
Study Start
September 25, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share