Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI. Currently, Medtronic Arctic Front cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel cryoballoon technology has recently been introduced (PolarX, Boston Scientific). However, whether PolarX provides effectiveness similar to the standard-of-practice Medtronic Arctic Front cryoballoon is yet to be investigated. Given that PolarX was developed considering the reported limitations and potential failures associated with the Medtronic Arctic Front cryoballoon, it might be even more effective and safe for use in AF ablation procedures. The aim of this trial is to compare the efficacy and safety of the PolarX Cryoballoon (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI. This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for single shot PVI and the PolarX is the novel technology, this trial has a non-inferiority design. The hypothesis with regards to the primary efficacy endpoint is that the PolarX Cryoballoon (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence the alternative hypothesis postulates that the PolarX Cryoballoon is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic). At the end of the procedure, an implantable cardiac monitor (Medtronic Reveal LINQ) will be implanted for the purpose of continuous arrhythmia monitoring.
Patients randomized to PolarX cryoballoon group will undergo PVI using the PolarX Cryoballoon (Boston Scientific). At the end of the procedure, an implantable cardiac monitor (Medtronic Reveal LINQ) will be implanted for the purpose of continuous arrhythmia monitoring.
University Hospital Basel
Basel, Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland
Number of Patients With Recurrence of Any Atrial Tachyarrhythmia
Number of patients with recurrence of any atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).
Time frame: days 91 to 365 post-ablation
Number of Participants With Complications
Composite endpoint composed of: * cardiac tamponade requiring drainage * persistent phrenic nerve palsy lasting \>24 hours * serious vascular complications requiring intervention * stroke/TIA * atrioesophageal fistula * death
Time frame: days 0 to 30 post-ablation
Total Procedure Time
Total procedure time from femoral vein puncture to sheath removal
Time frame: Day 1
Total Left Atrial (LA) Indwelling Time
Total LA indwelling time, from transseptal puncture to removal of LA catheters
Time frame: Day 1
Total Cryoablation Time
procedural endpoint
Time frame: Day 1
Total Number of Cryoapplications Per Patient/Per Vein
procedural endpoint
Time frame: Day 1
Time to Effect
disappearance of PV-Signal; procedural endpoint
Time frame: Day 1
Nadir Temperatures
procedural endpoint
Time frame: Day 1
Total Fluoroscopy Time
procedural endpoint
Time frame: Day 1
Radiation Dose
procedural endpoint
Time frame: Day 1
Contrast Agent Usage
unit measure ml; procedural endpoint
Time frame: Day 1
Number of Patients With Veins With PV Signals Visible Before Cryoablation
procedural endpoint
Time frame: Day 1
Number of Participants With Phrenic Nerve Palsy
procedural endpoint
Time frame: Day 1
Number of Patients With Recurrence of Atrial Tachyarrhythmia
Follow up Endpoint
Time frame: between days 1 and 90 after ablation
Overall AF Burden = % Time in AF
Assessed by the ICM Core Lab post implantation
Time frame: 91-365 days
Number of Hospital Admissions or Emergency Room Visits Because of Documented Recurrence of Atrial Arrhythmias
based on telephone follow-up
Time frame: Day 0 (after ablation) until day 365 post-ablation
Number of Electrical Cardioversion Because of Documented Recurrence of Atrial Arrhythmias
based on telephone follow-up
Time frame: Day 0 (post-ablation) to day 365 after ablation
Number of Repeat Ablation Procedure Because of Documented Recurrence of Atrial Arrhythmias
based on telephone follow-up
Time frame: Day 1 - 365 postablation
Evolution of Quality of Life (QoL)
Evolution of Quality of Life (QoL) from BL to 12 months. Patients rated their health on a scale from 0 to 100, with 100 being the best possible score and 0 the worst possible score. A positive number in the outcome measure means that BL's health has improved at 12 months. A negative number in the outcome measure means that BL's health has declined at 12 months.
Time frame: Change in score from BL to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.