"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

NCT05815745 | Recruiting DMC

• 1 other identifier: 22HH7931
• Study Type: interventional
• Target: 2,600
• Locations: 3 countries
• Sites: 45

Brief Summary

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

Bradycardia; Pacing; Right Ventricular Pacing; His Bundle Pacing; Left Bundle Branch Area Pacing

Outcome Measures

Primary Outcomes (2)

• Mortality

  Death, any cause

  From date of consent, until date of death from any cause, assessed up until 78 months.

• Heart Failure Morbidity

  Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit).

  From date of consent, assessed up until 78 months, or death from any cause, whichever came first.

Secondary Outcomes (10)

• Incidence of clinically indicated upgrade to conventional biventricular pacing (CRT device)

  From date of randomisation until the date of first documented incident of device upgrade, or death from any cause, whichever came first, assessed up to 78 months.

• Patient quality of life assessed via questionnaires (EQ-5D-5L) EQ-5D is the name of the instrument and is not an acronym.

  From date of consent, assessed up to 78 months or until death of any cause, whichever came first.

• Patient symptoms assessed on a scale of 0-100 monthly

  From one month after device implant date, assessed up to 78 months or until death of any cause, whichever came first.

• Safety endpoints: Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax

  From device implant date, assessed up to 78 months or until death of any cause, whichever came first.

• Pacemaker derived endpoints: a) Atrial fibrillation (duration >6minutes) b) Ventricular arrhythmia incidence c) Daily patient activity (hours stratified by device vendor)

  From device implant date, assessed up to 78 months or until death of any cause, whichever came first.

Study Arms (2)

Right ventricular pacing

ACTIVE COMPARATOR

Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)

Device: Pacemaker - Right Ventricular pacing

Physiological pacing

EXPERIMENTAL

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.

Device: Pacemaker - Physiological pacing

Interventions

Pacemaker - Physiological pacing DEVICE

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

Pacemaker - Right Ventricular pacing DEVICE

Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).

Right ventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following 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 may not qualify if:

• Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
• Pregnant women.
• Unable to provide informed consent.
• Those with comorbidity leading to a life expectancy \<1year.

Sponsors & Collaborators

• Imperial College London: lead
• British Heart Foundation: collaborator

Study Sites (45)

Beacon Hospital

Dublin, Ireland

RECRUITING

Univerisity Medical Centre Ljubljana

Ljubljana, Slovenia

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

RECRUITING

Queen's Hospital

Barking, United Kingdom

RECRUITING

Good Hope Hospital

Birmingham, United Kingdom

RECRUITING

Queen Elizabeth Hospital

Birmingham, United Kingdom

RECRUITING

University Hospital Dorset

Bournemouth, United Kingdom

RECRUITING

Royal SUSSEX County Hospital

Brighton, United Kingdom

RECRUITING

Bristol Heart Institute

Bristol, United Kingdom

RECRUITING

Royal Papworth Hospital

Cambridge, United Kingdom

RECRUITING

St Richard's Hospital

Chichester, United Kingdom

RECRUITING

University Hospital Coventry

Coventry, United Kingdom

RECRUITING

Croydon

Croydon, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

RECRUITING

Victoria Hospital

Fife Keith, United Kingdom

RECRUITING

Medway Maritime Hospital

Gillingham, United Kingdom

RECRUITING

Wycombe Hospital

High Wycombe, United Kingdom

RECRUITING

Forth Valley Royal Hospital

Larbert, United Kingdom

RECRUITING

Leeds Teaching Hospital

Leeds, United Kingdom

RECRUITING

Glenfield Hospital

Leicester, United Kingdom

RECRUITING

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

RECRUITING

Hammersmith Hospital

London, United Kingdom

RECRUITING

Kettering Hospital

London, United Kingdom

RECRUITING

King's College Hospital

London, United Kingdom

RECRUITING

Royal Free London/ Barnet Hospital

London, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, United Kingdom

RECRUITING

Watford General Hospital

London, United Kingdom

RECRUITING

James Cook Hospital

Middlesbrough, United Kingdom

RECRUITING

King's Mill Hospital

Nottingham, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, United Kingdom

RECRUITING

Queen Alexandra Hospital

Portsmouth, United Kingdom

RECRUITING

Royal Berkshire

Reading, United Kingdom

RECRUITING

East Surrey

Redhill, United Kingdom

RECRUITING

Rotherham General Hospital

Rotherham, United Kingdom

RECRUITING

Northern General

Sheffield, United Kingdom

RECRUITING

Wexham Park Hospital

Slough, United Kingdom

RECRUITING

Southampton

Southampton, United Kingdom

RECRUITING

Morriston Hospital

Swansea, United Kingdom

RECRUITING

Great Western

Swindon, United Kingdom

RECRUITING

Musgrove Park Hospital

Taunton, United Kingdom

RECRUITING

Torbay Hospital

Torquay, United Kingdom

RECRUITING

UHS Worthing

Worthing, United Kingdom

RECRUITING

York Hospital

York, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zachary Whinnett

CONTACT

+447749576830; z.whinnett@imperial.ac.uk

Daniel Keene

CONTACT

+442075949776; d.keene@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: April 18, 2023
• Study Start: June 5, 2023
• Primary Completion (Estimated): December 4, 2029
• Study Completion (Estimated): December 4, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

GB (43); IE (1); SL (1)