Improving exercise capacity in heart failure patients using conduction system pacing
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
This study is testing if a new type of heart pacing can help people with heart failure exercise better than the standard pacing method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06278844 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effects of conduction system pacing (CSP) compared to right ventricular apical pacing on exercise capacity in heart failure patients who require pacing but do not have a compelling indication for cardiac resynchronization therapy (CRT). The study will measure peak oxygen uptake (VO2peak) to assess improvements in exercise capacity over a 24-week follow-up period. Additionally, it aims to explore the mechanisms behind exercise intolerance in these patients. Eligible participants will be randomly assigned to receive either CSP or standard pacing, with regular evaluations to monitor heart function and safety concerns related to the pacing devices.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients with reduced ejection fraction or preserved ejection fraction who require pacing but do not meet the criteria for CRT.
Not a fit: Patients with a Class 1A indication for classical CRT or significant comorbidities that prevent maximal exercise testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance exercise capacity and overall heart function in certain heart failure patients.
How similar studies have performed: While conduction system pacing is a newer technique, preliminary studies suggest it may offer advantages over traditional pacing methods, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥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 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 ≥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 ...
Where this trial is running
Edegem, Antwerp
- Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Andreas Gevaert — University Hospital, Antwerp
- Study coordinator: Andreas Gevaert
- Email: Andreas.gevaert@uza.be
- Phone: 038213538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.