Status:

RECRUITING

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

Lead Sponsor:

Imperial College London

Collaborating Sponsors:

British Heart Foundation

Conditions:

Bradycardia

Pacing

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 s...

Detailed Description

Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing. Patients at sites participating in echo su...

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.

Key Trial Info

Start Date :

June 5 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 4 2029

Estimated Enrollment :

2600 Patients enrolled

Trial Details

Trial ID

NCT05815745

Start Date

June 5 2023

End Date

December 4 2029

Last Update

November 28 2025

Active Locations (45)

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Page 1 of 12 (45 locations)

1

Beacon Hospital

Dublin, Ireland

2

Univerisity Medical Centre Ljubljana

Ljubljana, Slovenia

3

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

4

Queen's Hospital

Barking, United Kingdom

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