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

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

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

Inclusion Criteria4

Patients with heart failure as defined by European Society of Cardiology guidelines
Signs and/or symptoms of heart failure
AND LVEF \<50% OR LVEF ≥50% and objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised filling pressures
AND indication for cardiac pacing as defined by European Society of Cardiology guidelines

Exclusion Criteria7

Age under 18 years old
Pregnancy
Inability to provide consent or to undergo follow-up
Class 1A indication for classical CRT as defined by European Society of Cardiology guidelines. Patients with a class 2A or higher indication for CRT can be included. However, patients with Class 1A indication for classical CRT but failure or suboptimal result of CS lead placement can be included.
Significant cardiac or extracardiac comorbidity precluding maximal exercise testing, examples: Recent (\<4 weeks) decompensation of heart failure, angina pectoris class ≥2 , uncontrolled hypertension or arrhythmia , severe valvular heart disease, significant peripheral vascular disease, orthopaedic limitation ...
Comorbidity that may influence 6-month prognosis, examples:
Severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (≥GOLD 3) , active malignancy ...

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.