Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-09-01

Brief Summary

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The goal of this retrospective observational study is to learn about the safety and efficacy of cryoballoon catheter ablation in 80 patients with persistent atrial fibrillation using the PolarX (Boston scientific) cryoablation technology. The main question it aims to answer is if it is safe and effective.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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catheter ablation

All patients underwent pulmonary vein isolation (and eventually left atrial posterior wall isolation) with the POLARx™ cryoballoon system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with PolarX cryoballoon

Exclusion Criteria

* previous atrial fibrillation ablation or cardiac surgery,
* paroxysmal atrial fibrillation,
* congenital heart disease,
* non-treated coronary artery disease,
* intracavitary thrombus,
* significant valvular disease,
* contraindications to general anesthesia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Carlo de Asmundis

Head of the department: Heart Rhythm Management Centre, Postgraduate Course in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Universitair Ziekenhuis

Responsibility Role PRINCIPAL_INVESTIGATOR