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

Launched by IMPERIAL COLLEGE LONDON · Apr 4, 2023

Keywords

ClinConnect Summary

The PROTECT-HF trial is studying two different methods of pacing the heart to help people with slow heart rates, a condition known as bradycardia. This trial will compare the traditional method, called right ventricular pacing, with a newer approach known as physiological pacing, which includes techniques called His bundle pacing and left bundle branch area pacing. The study will involve around 2,600 patients who will be randomly assigned to receive one of the two pacing methods. Researchers will monitor patients’ progress over time to see which method works better for maintaining heart health.

To participate in this trial, individuals must be over 18 years old and have a heart function that is still above a certain level, with specific heart rhythm issues that require a pacemaker. For example, those with various types of heart block or slow atrial fibrillation may qualify. Participants can expect to have their pacemaker implanted at one of the study centers, and their health will be monitored regularly for two years. Importantly, both patients and the assessors will not know which pacing method a participant receives to ensure an unbiased study. This trial aims to improve our understanding of how these pacing techniques affect heart function over time.

Gender

ALL

Eligibility criteria

• • We will recruit patients who are referred for clinically indicated pacemaker implantation
• Inclusion Criteria:
• 1. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based ventricular pacing indications:
• • 1. Permanent or intermittent 3rd degree AV block
• • 2. Permanent or intermittent Mobitz type II AV block
• • 3. First Degree AV block with a pacing indication
• • 4. Slow chronic Atrial Fibrillation or Proposed AV node ablation
• • 5. Bifascicular block with a pacing indication
• • 6. Trifascicular block with a pacing indication
• • 7. Wenckebach with a pacing indication
• Exclusion Criteria:
• • 1. Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
• • 2. Pregnant women.
• • 3. Unable to provide informed consent.
• • 4. Those with comorbidity leading to a life expectancy \<1year.