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His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction

NCT04529577 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-28

No results posted yet for this study

Summary

The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.

Conditions

  • His Bundle Pacing
  • Heart Failure, Systolic

Interventions

DEVICE

His-bundle pacing

A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated). A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Rasmus Borgquist, MD PhD · Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Sweden

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 NCT04529577 on ClinicalTrials.gov