Clinical trial NCT06183879: Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
Official title: Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ablation
cryoballoon
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to two different cryoballoon devices
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: acute success
timeFrame: 1 week
measure: mid term success
timeFrame: 1 year. Outpatient visits planned on 90, 180 and 360 days.
Secondary outcomes:
measure: procedure duration
timeFrame: 1 week
measure: fluoroscopy time
timeFrame: 1 week
measure: complications
timeFrame: 1 year
measure: ablation time
timeFrame: 1 week
measure: radiation dosage
timeFrame: 1 week
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: KB Dubrava
state: Please Select
city: Zagreb
country: Croatia
facility: KBC Zagreb
Study officials:
References: