"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
NCT ID: NCT05815745
Last Updated: 2025-11-28
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
2600 participants
INTERVENTIONAL
2023-06-05
2029-12-04
Brief Summary
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Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.
Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis.
2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover.
500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).
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Detailed Description
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Patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Right ventricular pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)
Pacemaker - Right Ventricular pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Physiological 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.
Pacemaker - Physiological 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.
Interventions
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Pacemaker - Physiological 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.
Pacemaker - Right Ventricular pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Eligibility Criteria
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Inclusion Criteria
1. Permanent or intermittent 3rd degree AV block
2. Permanent or intermittent Mobitz type II AV block
3. First Degree AV block with a pacing indication
4. Slow chronic Atrial Fibrillation or Proposed AV node ablation
5. Bifascicular block with a pacing indication
6. Trifascicular block with a pacing indication
7. Wenckebach with a pacing indication
Exclusion Criteria
2. Pregnant women.
3. Unable to provide informed consent.
4. Those with comorbidity leading to a life expectancy \<1year.
18 Years
ALL
No
Sponsors
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British Heart Foundation
OTHER
Imperial College London
OTHER
Responsible Party
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Locations
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Beacon Hospital
Dublin, , Ireland
Univerisity Medical Centre Ljubljana
Ljubljana, , Slovenia
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Queen's Hospital
Barking, , United Kingdom
Good Hope Hospital
Birmingham, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
University Hospital Dorset
Bournemouth, , United Kingdom
Royal SUSSEX County Hospital
Brighton, , United Kingdom
Bristol Heart Institute
Bristol, , United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
St Richard's Hospital
Chichester, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Croydon
Croydon, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Victoria Hospital
Fife Keith, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Wycombe Hospital
High Wycombe, , United Kingdom
Forth Valley Royal Hospital
Larbert, , United Kingdom
Leeds Teaching Hospital
Leeds, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Kettering Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Free London/ Barnet Hospital
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Watford General Hospital
London, , United Kingdom
James Cook Hospital
Middlesbrough, , United Kingdom
King's Mill Hospital
Nottingham, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Royal Berkshire
Reading, , United Kingdom
East Surrey
Redhill, , United Kingdom
Rotherham General Hospital
Rotherham, , United Kingdom
Northern General
Sheffield, , United Kingdom
Wexham Park Hospital
Slough, , United Kingdom
Southampton
Southampton, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Great Western
Swindon, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
UHS Worthing
Worthing, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Susana Ramos Vasquez
Role: primary
Role: backup
Provided Documents
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Document Type: Study Protocol: Protocol_v9.0_16.06.2025
Other Identifiers
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22HH7931
Identifier Type: -
Identifier Source: org_study_id
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