"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pacemaker - Physiological pacing
DeviceThe 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
DeviceRight ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Treatment groups
2,600 Participants
are divided into 2 treatment groupsGroup A: Right ventricular pacingActive comparator 1 intervention
Group B: Physiological pacingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Death, any cause
Time frame
From date of consent, until date of death from any cause, assessed up until 78 months.2
Heart Failure Morbidity
Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit).
Time frame
From date of consent, assessed up until 78 months, or death from any cause, whichever came first.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.
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.
Time frame
From date of consent, assessed up to 78 months or until death of any cause, whichever came first.3
Patient symptoms assessed on a scale of 0-100 monthly
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.
Time frame
From one month after device implant date, assessed up to 78 months or until death of 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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
British Heart Foundation
Collaborator
Source ClinicalTrials.gov