NCT06278844

Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.

Detailed description

Heart failure (HF) is a serious condition that affects a lot of people and places a significant burden on the healthcare system. Some HF patients also have issues with the natural electrical system of their heart, causing uneven heart contractions and worsening heart function. A treatment known as CRT has been helping such patients, but it does not work for everyone. A new technique called conduction system pacing (CSP) has emerged that might offer a more natural way of maintaining heart contractions. This study aims to determine if CSP can enhance the ability of HF patients to exercise, by looking at their maximum oxygen consumption (a measure of exercise capacity). It will also explore why some HF patients struggle with exercise more than others. Eligible patients will be randomly assigned to either the new CSP treatment or a standard pacing method (right ventricular apical pacing). Patients will be checked regularly over a follow-up period of 24 weeks. The main goal is to see if patients can exercise better with CSP after 24 weeks. The study will also look at other heart measures and safety concerns related to the devices. This study might show that CSP can help improve exercise capacity and heart function in certain HF patients. The results could guide health care professionals in offering better, tailored treatments for their patients.

Conditions

• Heart Failure With Reduced Ejection Fraction
• Heart Failure With Preserved Ejection Fraction
• Heart Conduction Disorder

Interventions

Type	Name	Description
DEVICE	Conduction system pacing	In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing. In the usual care group, the right ventricular lead will be placed in the right ventricle apex as usual.
DEVICE	Right ventricular apical pacing	This is the usual care group. Patients will receive a pacemaker device with the right ventricular lead inserted in the apex and not in the septal position.

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-09-01
• Completion: 2027-12-01
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study