Registry of Atrial Fibrillation Ablation Using a Balloon Catheter
Multielectrode Radiofrequency Balloon for Atrial Fibrillation Catheter Ablation: A Multicenter Real-World Experience
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06333327 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are symptomatic patients with atrial fibrillation who require catheter ablation.
Not a fit: Patients under 18 years old, pregnant women, or those with contraindications to catheter ablation will not benefit from this study.
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 performed: Other studies using similar radiofrequency balloon catheter approaches have shown promising results, indicating potential for success in this registry.
Eligibility criteria
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 this trial is running
Brussels
- 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
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.