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

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)
* Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization to two different cryoballoon devices
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medtronic 4th gen balloon<br>Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon | Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)<br>* Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon<br>|
| Active Comparator: Boston 2nd gen balloon<br>Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon | Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)<br>* Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute success | successful pulmonary vein isolation, as percentage of all pulmonary veins treated | 1 week | 
| mid term success | number of patients free from atrial arrhythmia (atrial fibrillation detected by ECG or Holter monitors on follow up visits) | 1 year. Outpatient visits planned on 90, 180 and 360 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure duration | duration of the procedure in minutes | 1 week | 
| fluoroscopy time | fluoroscopy time (minutes) | 1 week | 
| complications | number of minor (groin hematoma, chest pain, etc) or major complications (tamponade, phrenic nerve palsy, etc) | 1 year | 
| ablation time | cumulative time of cryo applications in seconds | 1 week | 
| radiation dosage | radiation dosage (microGrays-m2) | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, ablation, cryoballoon