Vergleich von zwei Kälteballons für die Verödungsbehandlung von wiederkehrendem Vorhofflimmern

Device: PVI using the Arctic Front Cryoballoon (Medtronic);Drug: PVI using the PolarX Cryoballoon (Boston Scientific)

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Paroxysmal atrial fibrillation documented on a 12 lead electrocardiogram (ECG) or
Holter monitor (lasting =30 seconds) within the last 24 months. According to current
guidelines, paroxysmal is defined as any atrial fibrillation (AF) that converts to
sinus rhythm within 7 days either spontaneously or by pharmacological or electrical
cardioversion.

- Candidate for ablation based on current AF guidelines

- Continuous anticoagulation with warfarin (International Normalized Ratio [INR] 2-3) or
a novel oral anticoagulant (NOAC) for =4 weeks prior to the ablation; or a
transesophageal echocardiogram (TEE) that excludes left atrial (LA) thrombus =48 hours
before ablation

- Age of 18 years or older on the date of consent

- Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

- Previous LA ablation or LA surgery

- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)

- Intracardiac thrombus

- Pre-existing pulmonary vein stenosis or pulmonary vein stent

- Pre-existing hemidiaphragmatic paralysis

- Contraindication to anticoagulation or radiocontrast materials

- Cardiac valve prosthesis

- Clinically significant (moderately-severe or severe) mitral regurgitation or stenosis

- Myocardial infarction, percutaneous coronary intervention (PCI)/ percutaneous
transluminal coronary angioplasty (PTCA), or coronary artery stenting during the
3-month period preceding the consent date

- Cardiac surgery during the three-month interval preceding the consent date or
scheduled cardiac surgery/transcatheter aortic valve implantation (TAVI) procedure

- Significant congenital heart defect (including atrial septal defects or pulmonary vein
abnormalities but not including patent foramen ovale)

- New York Heart Association (NYHA) class III or IV congestive heart failure

- Left ventricular ejection fraction (LVEF) <35%

- Hypertrophic cardiomyopathy (wall thickness >1.5 cm)

- Significant chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR]
<30 ?Mol/L)

- Uncontrolled hyperthyroidism

- Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the
consent date

- Ongoing systemic infections

- History of cryoglobulinemia

- Pregnancy*

- Life expectancy less than one (1) year per physician opinion

- Currently participating in any other clinical trial of a drug, device or biological
material during the duration of this study.

- Unwilling or unable to comply fully with study procedures and follow-up.

- To exclude pregnancy a blood test (human chorionic gonadotropin [HCG]) is used.