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NCT Number: NCT05815745

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

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).

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases His Bundle Pacing Left Bundle Branch Area Pacing Pacing Pathologic Processes Pathological Conditions, Signs and Symptoms Right Ventricular Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beacon Hospital, Dublin, Ireland

Loading trial locations.

About this study

Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

We will recruit patients who are referred for clinically indicated pacemaker implantation

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Pacemaker - Right Ventricular pacing

Device

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

Primary outcomes

  1. Mortality

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

    Death, any cause

  2. Heart Failure Morbidity

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

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

Secondary outcomes

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

    Time frame: 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.

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

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

    The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ 'visual analogue scale' (EQ VAS).

    The descriptive system is made up of 5 sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    A High score on the descriptive section means a worse health outcome. A Low score on the descriptive section means a better health outcome. A value set is required to convert the outcomes into scores.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative (numerical) measure of health outcome that reflect the patient's own judgement.

    A high score on the VAS means a better outcome. A low score on the VAS means a worse outcome.

  3. Patient symptoms assessed on a scale of 0-100 monthly

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

    This questionnaire will be sent to participants on a monthly basis for the duration of the study, 78 months from one month post pacemaker implant until end of study (78 months) or death from any cause, whichever came first.

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

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

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

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

  6. Patient quality of life assessed via questionnaires '36-Item Short Form Health Survey' (SF-36)

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

    A high score defines a more favourable health state. Range 0 to 100.

  7. Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within group differences

    Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).

    Within group differences of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation.

  8. Echo Sub-Study Endpoint: Ejection Fraction (EF) within patient changes

    Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).

    Within patient changes in Ejection Fraction will be assessed for differences according to treatment allocation.

  9. Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within patient changes

    Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).

    Within patient changes of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation

  10. Echo Sub-Study Endpoint: Ejection Fraction (EF) within group differences

    Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).

    Within group differences in Ejection Fraction will be assessed for differences according to treatment allocation.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Keene

CONTACT

[email protected]

+442075949776

Zachary Whinnett

CONTACT

[email protected]

+447749576830

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • British Heart Foundation

Registry information

Official study title

Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment

Acronym: PROTECT-HF

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Apr 18, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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