Registry of Atrial Fibrillation Ablation Using a Balloon Catheter
Official title: Multielectrode Radiofrequency Balloon for Atrial Fibrillation Catheter Ablation: A Multicenter Real-World Experience
Run by Universitair Ziekenhuis Brussel · NCT06333327 · Data updated 2026-11-12
This study is testing the safety and effectiveness of a new balloon catheter procedure for treating atrial fibrillation in real-life patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | January 1, 2030 |
| Study ends | December 1, 2030 |
| Registry record updated | March 27, 2024 |
| Trial ID | NCT06333327 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are symptomatic patients with atrial fibrillation who require catheter ablation.
✕Probably not a fit
Patients under 18 years old, pregnant women, or those with contraindications to catheter ablation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry includes all consecutive patients with paroxysmal or persistent atrial fibrillation who are undergoing pulmonary vein isolation using the radiofrequency balloon catheter 'Heliostar'. The study aims to evaluate the safety and arrhythmic outcomes of this ablation technique in a real-world clinical setting. The procedure involves precise positioning of the catheter and temperature-controlled ablation to achieve effective isolation of the pulmonary veins. Follow-up assessments will be conducted according to standard institutional protocols to monitor patient outcomes.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of atrial fibrillation ablation procedures for patients.
How similar studies have gone: Other studies using similar radiofrequency balloon catheter approaches have shown promising results, indicating potential for success in this registry.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * symptomatic atrial fibrillation with indication to catheter ablation Exclusion Criteria: * age \<18 years old * pregnancy * any contraindications to catheter ablation
Where it's running
-
UZ Brussel Heart Rhythm Management Center
Brussels, Belgium Recruiting
Study contacts
- Study coordinator: Alexandre Almorad, MD
- Email: alexandre.almorad@uzbrussel.be
- Phone: +32 2 4776009
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.