RecruitingNot ApplicableNCT06278844

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


Sponsor

University Hospital, Antwerp

Enrollment

75 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a newer pacing technique called Conduction System Pacing (CSP) — which delivers electrical signals more naturally through the heart's own wiring — improves exercise capacity and heart function compared to standard pacing in heart failure patients who need a pacemaker but do not have a strong indication for traditional cardiac resynchronization therapy (CRT). **You may be eligible if...** - You have heart failure with either reduced or mildly reduced heart pumping function - You need a pacemaker as indicated by current heart failure guidelines - You have signs or symptoms of heart failure confirmed by your doctor **You may NOT be eligible if...** - You are under 18 years old or pregnant - You have a strong guideline-based indication for traditional CRT (unless CRT lead placement failed) - You have recent heart failure hospitalization (within 4 weeks), uncontrolled arrhythmia or high blood pressure, severe valve disease, or severe vascular/orthopedic limitations to exercise testing - You have severe kidney disease (very low kidney function or on dialysis), severe COPD, or active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEConduction 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.

DEVICERight 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.


Locations(1)

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, Belgium

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NCT06278844


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