Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation (CRYO-LATS)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring PVI Ablation, Cryoballoon
Eligibility Criteria
Inclusion Criteria:
- Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
- Age of 18 years or older on the date of consent
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Exclusion Criteria:
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active Intracardiac Thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
- Cardiac valve prosthesis
- Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / 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
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) less than 35%
- Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- Significant Chronic Kidney Disease (CKD - eGFR <30 µMol/L)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- Pregnancy
- Life expectancy less than one (1) year
- Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
- Unwilling or unable to comply fully with study procedures and follow-up
Sites / Locations
- St. Paul's Hospital
- Vancouver General Hospital, University of British Columbia
- Queen Elizabeth II
- Southlake Regional Health Centre
- Université Laval
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Baylis transseptal system group
Conventional transseptal group
Patients randomized to the Baylis transseptal system group (Bayliss Group) will undergo transseptal puncture with a large, preformed curve 71-cm-C1 or 98-cm-C1 18-gauge NRG needle (Baylis Medical) through a TorFlex sheath (Baylis Medical), with the sheath curve selected at the discretion of the operating physician.
Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with either a large, preformed curve 71- or 98-cm 18-gauge BRK needle (BRK, BRK-1, BRK-2 needle, St. Jude Medical) through any non-Baylis sheath (for example Schwartz SL, Biosense-Webster Preface) selected at the discretion of the operating physician.