Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, ablation, cryoballoon
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.
Interventions
DEVICEcryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
DEVICEcryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization to two different cryoballoon devices
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| complications | 1 year | number of minor (groin hematoma, chest pain, etc) or major complications (tamponade, phrenic nerve palsy, etc) |
| procedure duration | 1 week | duration of the procedure in minutes |
| radiation dosage | 1 week | radiation dosage (microGrays-m2) |
| ablation time | 1 week | cumulative time of cryo applications in seconds |
| fluoroscopy time | 1 week | fluoroscopy time (minutes) |
Countries
Croatia
Contacts
Primary ContactVedran Velagic, MD, PhD
Outcome results
None listed