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Physiological versus Right ventricular pacing Outcome Trial Evaluated for bradyCardia Treatment

PROTECT-HF

Physiological versus Right ventricular pacing Outcome Trial Evaluated for bradyCardia Treatment

Lead PI & Sponsor

Dr. Daniel Keene

Local PI

Dr. Habib Khan

Research Staff

Sara El-Richani

Objective

  • Does physiological pacing reduce mortality and unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy)?
  • Does physiological pacing improve daily patient activity and patient reported quality of life?
  • Does physiological pacing reduce the need for later upgrade to biventricular pacemaker?
  • Does physiological pacing better maintain cardiac function (Left Ventricular Volumes and Ejection Fraction)?

Target Number of Patients

100

Currently Enrolled

8

Primary Outcomes

  • Death and unplanned heart failure acute care

Inclusion Criteria

  • Adults aged 18 or above with
  • Left ventricular ejection fraction >35% from any clinical echocardiogram performed any time in the 12 months prior to study enrolment.
  • And one or more of the following guideline based ventricular pacing indications:
    a. Permanent or intermittent 3rd degree AV block
    b. Permanent or intermittent Mobitz type II AV block
    c. First Degree AV block with a pacing indication
    d. Slow chronic Atrial Fibrillation or Proposed AV node ablation
    e. Bifasicular block with a pacing indication
    f. Trifasicular block with a pacing indication
    g. 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 comorbidities leading to a life expectancy < 1 year

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 utilise the same pacemaker device, the difference in this study is the location within the heart that one of the leads will be positioned.This trial will aim to establish whether preserving the heart’s normal activation sequence using physiological pacing results in an improvement in heart function and also fewer deaths when compared to standard RV pacing. The study is important as it will allow us to know what the best pacing approach is for people with slow heart rates in the future.

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