Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05815745

"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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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