Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation
NCT ID: NCT03199703
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2017-01-17
2020-08-01
Brief Summary
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The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Baylis transseptal system 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.
Baylis transseptal system group
Conventional transseptal group
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.
Standard conventional transseptal group
Interventions
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Baylis transseptal system group
Standard conventional transseptal group
Eligibility Criteria
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Inclusion Criteria
* Age of 18 years or older on the date of consent
* Candidate for ablation based on AF that is symptomatic
* Informed Consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Baylis Medical Company
INDUSTRY
Jason Andrade
OTHER
Responsible Party
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Jason Andrade
MD FRCPC FHRS
Locations
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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
Université Laval
Québec, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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References
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Andrade JG, Macle L, Bennett MT, Hawkins NM, Essebag V, Champagne J, Roux JF, Makanjee B, Tang A, Skanes A, Khaykin Y, Morillo C, Jolly U, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Wells GA, Verma A, Deyell MW. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. J Interv Card Electrophysiol. 2022 Nov;65(2):481-489. doi: 10.1007/s10840-022-01277-y. Epub 2022 Jun 24.
Other Identifiers
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6-May-16
Identifier Type: -
Identifier Source: org_study_id