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

University of Zagreb

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon); Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)

Study type: Interventional

Funder types: Other

Identifiers

NCT06183879

PolarvsAFA

Details and patient eligibility

About

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.

Full description

Patients suffering from paroxysmal atrial fibrillation who are scheduled (independently of this study) for cryoballoon pulmonary vein isolation will be informed about the study and potential risks. All patients who give written informed consent will be randomized to 4th generation Artic Front Advance Pro device (fixed size balloon of 28 mm) and Polar X Fit device (28-31 mm expandable balloon). The ablation procedure will be performed in standard of care fashion. Also, standard postprocedural follow up of the patients will be scheduled with outpatient clinic visits and 24-hour Holters and 3, 6 and 12 months, and yearly thereafter. Extra visits will be scheduled in the case of symptoms/palpitations.

Standard patient and procedural data will be collected alongside with the information obtained in the follow up.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Medtronic 4th gen balloon

Active Comparator group

Description:

Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon

Treatment:

Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)

Boston 2nd gen balloon

Active Comparator group

Description:

Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon

Treatment:

Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)