Objective
PROTECT-HF asks whether physiological pacing reduces mortality and unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy); improves daily patient activity and patient-reported quality of life; reduces the need for later upgrade to a biventricular pacemaker; and better maintains cardiac function (left ventricular volumes and ejection fraction), compared with standard right ventricular pacing.
Background
The PROTECT-HF trial will compare two different pacing approaches for treating patients at risk of, or who already have, slow heart rates. We will compare the standard approach for pacing, which involves placing a pacing lead into the right ventricle ("RV pacing"), with a new form of pacing, "physiological pacing." Both approaches use the same pacemaker device; the difference in this study is the location within the heart that one of the leads is positioned. This trial aims to establish whether preserving the heart's normal activation sequence using physiological pacing results in an improvement in heart function and fewer deaths when compared to standard RV pacing.
Study Outcomes
Primary
- Death and unplanned heart failure acute care
Secondary
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Adults aged 18 or above
- Left ventricular ejection fraction > 35% from any clinical echocardiogram performed in the 12 months prior to study enrolment
- One or more guideline-based ventricular pacing indications (e.g. permanent or intermittent 3rd degree AV block, Mobitz type II AV block, first degree AV block with a pacing indication, slow chronic AF or proposed AV node ablation, bifascicular or trifascicular block with a pacing indication, or Wenckebach with a pacing indication)
Exclusion Criteria
- Patients likely to only need occasional ventricular pacing (e.g. those with isolated sick sinus syndrome)
- Pregnant women
- Unable to provide informed consent
- Comorbidities leading to a life expectancy < 1 year
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.