RecruitingNot ApplicableNCT06183879

Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation

Sponsor

University of Zagreb

Enrollment

150 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF). The main aims of the study are: * to compare the efficacy of two ablation devices (acute and 1 year success rates) * to compare the procedural characteristics (procedure duration, fluoroscopy duration, ablation time * to compare the complication rates Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon. Standard of care cryoballoon procedure will be performed alongside with standard postprocedural follow-up. • to compare the complication rates Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of cryoballoon catheters used to treat paroxysmal atrial fibrillation (PAF) — an irregular heartbeat that comes and goes. The procedure (cryoballoon pulmonary vein isolation) freezes the tissue around the pulmonary veins in the heart to stop the abnormal electrical signals causing the arrhythmia. The study compares an expandable balloon (which adjusts its size) against a fixed-size balloon. **You may be eligible if...** - You have been diagnosed with paroxysmal atrial fibrillation (afib that starts and stops on its own) - Your cardiologist has already scheduled you for a cryoballoon ablation procedure regardless of this study **You may NOT be eligible if...** - You are unwilling to sign informed consent - Your left atrium (heart chamber) is enlarged beyond 55mm - You have uncontrolled heart failure (NYHA Class III or IV) - You have blood clots in the heart Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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