What is this trial studying for slow heart rates (bradycardia)?

This trial is studying how two different pacemaker pacing methods, right ventricular pacing and physiological pacing, affect patients with slow heart rates. The study aims to compare these approaches to understand their impact on survival, heart failure, and quality of life. Imperial College London is leading this research to improve pacing treatments.

Who may be eligible for this bradycardia clinical trial?

Adults aged 18 or older who need a pacemaker and have a left ventricular ejection fraction above 35% may be eligible. Participants must have specific heart block conditions or pacing indications. Pregnant women and those with a life expectancy under one year cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this bradycardia clinical trial?

Study-related care, including the pacemaker device, procedures, and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05815745

Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment

Led by Imperial College London · Updated on 2025-11-28

2600

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two different pacing methods for patients with slow heart rates in this multi-center trial. The study compares the standard right ventricular pacing with a newer physiological pacing approach, which includes His bundle pacing or left bundle pacing. This trial aims to better understand the effects of these pacing methods on heart function and patient outcomes over time, including a sub-study focused on heart muscle changes related to pacing. Participants will receive a pacemaker implanted at a participating center and be randomly assigned to either right ventricular pacing or physiological pacing. For physiological pacing, if His or left bundle pacing is not successful, biventricular pacing will be used instead. The trial includes an optional echocardiographic sub-study for some patients to assess heart changes over 24 months. Participants will be followed for up to 78 months, with assessments at baseline and every six months. Researchers will measure outcomes such as survival, heart failure events, quality of life questionnaires, symptoms, device-related safety events, and heart rhythm data collected from the pacemakers. The sub-study will use echocardiograms to evaluate changes in heart volume and pumping efficiency. This comprehensive follow-up aims to capture both clinical effects and mechanistic insights of the pacing methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged over 18 with left ventricular ejection fraction greater than 35%
Presence of one or more guideline-based ventricular pacing indications such as permanent or intermittent 3rd degree AV block, Mobitz type II AV block, first degree AV block with pacing indication
Slow chronic atrial fibrillation or proposed AV node ablation
Bifascicular or trifascicular block with pacing indication
Wenckebach with pacing indication
Patients referred for clinically indicated pacemaker implantation

You will not qualify if you...

Patients likely to only need occasional ventricular pacing, such as those with isolated sick sinus syndrome
Pregnant women
Unable to provide informed consent
Patients with comorbidities leading to life expectancy less than 1 year

Research Team

Zachary Whinnett

Daniel Keene

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here