This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system. The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Study Objective - The objective of the prospective, randomized study is to evaluate the effectiveness and safety of the Baylis transseptal system (RF needle, TorFlex sheath, and specialised ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures. Trial design - This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system. Study Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
St. Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital, University of British Columbia
Vancouver, British Columbia, Canada
Queen Elizabeth II
Halifax, Nova Scotia, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Total time required for left atrial access
defined as time from the first pull-down of the needle/sheath/dilator apparatus in the superior vena cava to first entrance of the cryoballoon into the left atrium.
Time frame: Intraprocedural assessment (within 24 hours)
Transeptal Access
Success/failure of the assigned transseptal apparatus to achieve transeptal puncture (proportion of patients necessitating the use of the alternate study apparatus - e.g. cross-over from the NRG RF needle to the to conventional BRK needle)
Time frame: Intraprocedural assessment (within 24 hours)
Plastic Shavings
Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen
Time frame: Intraprocedural assessment of visible plastic shavings (within 24 hours)
The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture
Events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture
Time frame: Acute peri-procedural complications will be defined as occurring within 30 days of ablation
Transseptal time - septal engagement to sheath advancement
Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA
Time frame: Intraprocedural assessment (measured in seconds)
Transseptal time - left atrial access to sheath positioning
Time from needle advancement through the septum to sheath advancement into the LA
Time frame: Intraprocedural assessment (measured in seconds)
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Université Laval
Québec, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada