Actively Recruiting
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Led by Imperial College London · Updated on 2025-11-28
2600
Participants Needed
45
Research Sites
339 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
B
British Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients. 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).
CONDITIONS
Official Title
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 with left ventricular ejection fraction >35%
- Patients referred for clinically indicated pacemaker implantation
- Presence of one or more guideline-based ventricular pacing indications: permanent or intermittent 3rd degree AV block
- Permanent or intermittent Mobitz type II AV block
- First degree AV block with a pacing indication
- Slow chronic atrial fibrillation or proposed AV node ablation
- Bifascicular block with a pacing indication
- Trifascicular block with a pacing indication
- Wenckebach with a pacing indication
You will not qualify if you...
- Patients likely to need only occasional ventricular pacing, such as those with isolated sick sinus syndrome
- Pregnant women
- Unable to provide informed consent
- Coexisting illness limiting life expectancy to less than one year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 45 locations
1
Beacon Hospital
Dublin, Ireland
Actively Recruiting
2
Univerisity Medical Centre Ljubljana
Ljubljana, Slovenia
Actively Recruiting
3
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Actively Recruiting
4
Queen's Hospital
Barking, United Kingdom
Actively Recruiting
5
Good Hope Hospital
Birmingham, United Kingdom
Actively Recruiting
6
Queen Elizabeth Hospital
Birmingham, United Kingdom
Actively Recruiting
7
University Hospital Dorset
Bournemouth, United Kingdom
Actively Recruiting
8
Royal SUSSEX County Hospital
Brighton, United Kingdom
Actively Recruiting
9
Bristol Heart Institute
Bristol, United Kingdom
Actively Recruiting
10
Royal Papworth Hospital
Cambridge, United Kingdom
Actively Recruiting
11
St Richard's Hospital
Chichester, United Kingdom
Actively Recruiting
12
University Hospital Coventry
Coventry, United Kingdom
Actively Recruiting
13
Croydon
Croydon, United Kingdom
Actively Recruiting
14
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Actively Recruiting
15
Victoria Hospital
Fife Keith, United Kingdom
Actively Recruiting
16
Medway Maritime Hospital
Gillingham, United Kingdom
Actively Recruiting
17
Wycombe Hospital
High Wycombe, United Kingdom
Actively Recruiting
18
Forth Valley Royal Hospital
Larbert, United Kingdom
Actively Recruiting
19
Leeds Teaching Hospital
Leeds, United Kingdom
Actively Recruiting
20
Glenfield Hospital
Leicester, United Kingdom
Actively Recruiting
21
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Actively Recruiting
22
Hammersmith Hospital
London, United Kingdom
Actively Recruiting
23
Kettering Hospital
London, United Kingdom
Actively Recruiting
24
King's College Hospital
London, United Kingdom
Actively Recruiting
25
Royal Free London/ Barnet Hospital
London, United Kingdom
Actively Recruiting
26
St Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
27
Watford General Hospital
London, United Kingdom
Actively Recruiting
28
James Cook Hospital
Middlesbrough, United Kingdom
Actively Recruiting
29
King's Mill Hospital
Nottingham, United Kingdom
Actively Recruiting
30
Nottingham City Hospital
Nottingham, United Kingdom
Actively Recruiting
31
John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
32
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
33
Queen Alexandra Hospital
Portsmouth, United Kingdom
Actively Recruiting
34
Royal Berkshire
Reading, United Kingdom
Actively Recruiting
35
East Surrey
Redhill, United Kingdom
Actively Recruiting
36
Rotherham General Hospital
Rotherham, United Kingdom
Actively Recruiting
37
Northern General
Sheffield, United Kingdom
Actively Recruiting
38
Wexham Park Hospital
Slough, United Kingdom
Actively Recruiting
39
Southampton
Southampton, United Kingdom
Actively Recruiting
40
Morriston Hospital
Swansea, United Kingdom
Actively Recruiting
41
Great Western
Swindon, United Kingdom
Actively Recruiting
42
Musgrove Park Hospital
Taunton, United Kingdom
Actively Recruiting
43
Torbay Hospital
Torquay, United Kingdom
Actively Recruiting
44
UHS Worthing
Worthing, United Kingdom
Actively Recruiting
45
York Hospital
York, United Kingdom
Actively Recruiting
Research Team
Z
Zachary Whinnett
CONTACT
D
Daniel Keene
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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