Actively Recruiting
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
Led by University Hospital, Antwerp · Updated on 2024-02-26
75
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with heart failure as defined by European Society of Cardiology guidelines
- Presence of signs and/or symptoms of heart failure
- Left ventricular ejection fraction (LVEF) below 50% or LVEF 50% or above with evidence of cardiac structural or functional abnormalities consistent with left ventricular diastolic dysfunction or raised filling pressures
- Indication for cardiac pacing according to European Society of Cardiology guidelines
You will not qualify if you...
- Age under 18 years old
- Pregnancy
- Inability to provide consent or to undergo follow-up
- Class 1A indication for classical cardiac resynchronization therapy (CRT), except patients with failure or suboptimal results of conduction system lead placement
- Significant cardiac or extracardiac conditions preventing maximal exercise testing (e.g., recent heart failure decompensation within 4 weeks, angina class 2 or higher, uncontrolled hypertension or arrhythmia, severe valvular heart disease, significant peripheral vascular disease, orthopedic limitations)
- Comorbidities that may affect 6-month prognosis such as severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis), severe chronic obstructive pulmonary disease (GOLD stage 3 or higher), active malignancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
A
Andreas Gevaert
CONTACT
F
Faro Verelst
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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