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:
- Permanent or intermittent 3rd degree AV block
- Permanent or intermittent Mobitz type II AV block
- First Degree AV block with a pacing indication
- Slow chronic Atrial Fibrillation or Proposed AV node ablation
- Bifascicular block with a pacing indication
- Trifascicular block with a pacing indication
- 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 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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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