๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
Patients with heart failure as defined by European Society of Cardiology guidelines
* Signs and/or symptoms of heart failure
* AND LVEF \<50% OR LVEF โฅ50% 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 Criteria:
* 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 โฅ2 , 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 โค20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (โฅGOLD 3) , active malignancy ...
๐
What it tests
- Conduction system pacing
- Right ventricular apical pacing
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.