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

RECRUITINGN/ASponsored by University of Zagreb
Actively Recruiting
PhaseN/A
SponsorUniversity of Zagreb
Started2024-01-01
Est. completion2025-01-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06183879

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Atrial FibrillationHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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