Status:
ACTIVE_NOT_RECRUITING
Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 freq...
Eligibility Criteria
Inclusion
- 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
- 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 μMol/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.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04704986
Start Date
March 29 2021
End Date
July 31 2025
Last Update
February 19 2025
Active Locations (2)
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1
University Hospital Basel
Basel, Switzerland, 4031
2
Inselspital, Bern University Hospital
Bern, Switzerland, 3010