NCT05815745

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

Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,600 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.

Conditions

• Bradycardia
• Pacing
• Right Ventricular Pacing
• His Bundle Pacing
• Left Bundle Branch Area Pacing

Interventions

Type	Name	Description
DEVICE	Pacemaker - Physiological pacing	The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
DEVICE	Pacemaker - Right Ventricular pacing	Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).

Timeline

• Start date: 2023-06-05
• Primary completion: 2029-12-04
• Completion: 2029-12-04
• First posted: 2023-04-18
• Last updated: 2025-11-28

Locations

45 sites across 3 countries: Ireland, Slovenia, United Kingdom