NCT05815745 "Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
| NCT ID | NCT05815745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Bradycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,600 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2031-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,600 participants in total. It began in 2023-06-05 with a primary completion date of 2031-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients. Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient. Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis. 2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover. 500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05815745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05815745 currently recruiting?
Yes, NCT05815745 is actively recruiting participants. Contact the research team at z.whinnett@imperial.ac.uk for enrollment information.
Where is the NCT05815745 trial being conducted?
This trial is being conducted at Dublin, Ireland, Ljubljana, Slovenia, Aberdeen, United Kingdom, Barking, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05815745 clinical trial?
NCT05815745 is sponsored by Imperial College London. The trial plans to enroll 2,600 participants.