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

NCT05815745 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2600

Last updated 2025-11-28

No results posted yet for this study

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).

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • Imperial College London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2029-12-04
Completion
2029-12-04

Countries

  • Ireland
  • Slovenia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815745 on ClinicalTrials.gov