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
Inclusion
- We will recruit patients who are referred for clinically indicated pacemaker implantation
- 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
- 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)
Enter a location and click search to find clinical trials sorted by distance.
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