Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
- Registration Number
- NCT06183879
- Lead Sponsor
- University of Zagreb
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- paroxysmal atrial fibrillation
- patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
- unwilling to sing the informed consent Left atrium size > 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medtronic 4th gen balloon cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon) Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon Boston 2nd gen balloon cryoballoon pulmonary vein isolation (Boston 2nd gen balloon) Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon
- Primary Outcome Measures
Name Time Method acute success 1 week successful pulmonary vein isolation, as percentage of all pulmonary veins treated
mid term success 1 year. Outpatient visits planned on 90, 180 and 360 days. number of patients free from atrial arrhythmia (atrial fibrillation detected by ECG or Holter monitors on follow up visits)
- Secondary Outcome Measures
Name Time Method ablation time 1 week cumulative time of cryo applications in seconds
radiation dosage 1 week radiation dosage (microGrays-m2)
fluoroscopy time 1 week fluoroscopy time (minutes)
procedure duration 1 week duration of the procedure in minutes
complications 1 year number of minor (groin hematoma, chest pain, etc) or major complications (tamponade, phrenic nerve palsy, etc)
Trial Locations
- Locations (2)
KB Dubrava
🇭🇷Zagreb, Please Select, Croatia
KBC Zagreb
🇭🇷Zagreb, Croatia