Comparing two cryoballoon devices for treating atrial fibrillation
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
This study is testing two different cryoballoon devices to see which one works better and is safer for treating people with paroxysmal atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Zagreb Academic / other |
| Locations | 2 sites (Zagreb, Please Select and 1 other locations) |
| Trial ID | NCT06183879 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of two cryoballoon devices used for the treatment of paroxysmal atrial fibrillation. Participants scheduled for cryoballoon pulmonary vein isolation will be randomly assigned to receive either a fixed size or an expandable cryoballoon. The study will evaluate the success rates of the procedures, the duration of the procedures, and the rates of complications. Standard post-procedural follow-up will be conducted to monitor patient outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with paroxysmal atrial fibrillation who are scheduled for cryoballoon pulmonary vein isolation.
Not a fit: Patients with uncontrolled heart failure, significant left atrium enlargement, or those unwilling to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with paroxysmal atrial fibrillation.
How similar studies have performed: Previous studies have shown promising results with cryoballoon ablation techniques, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * paroxysmal atrial fibrillation * patient scheduled for cryoballoon pulmonary vein isolation regardless of this study Exclusion Criteria: * unwilling to sing the informed consent Left atrium size \> 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Where this trial is running
Zagreb, Please Select and 1 other locations
- KB Dubrava — Zagreb, Please Select, Croatia (Recruiting)
- KBC Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Study coordinator: Vedran Velagic, MD, PhD
- Email: vvelagic@gmail.com
- Phone: +385917929284
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.