- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199703
Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation (CRYO-LATS)
Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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Vancouver, British Columbia, Canada
- Vancouver General Hospital, University of British Columbia
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Queen Elizabeth II
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Ontario
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Newmarket, Ontario, Canada
- Southlake Regional Health Centre
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Quebec
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Quebec City, Quebec, Canada
- Université Laval
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- University of Saskatchewan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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Active Comparator: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total time required for left atrial access
Time Frame: Intraprocedural assessment (within 24 hours)
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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.
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Intraprocedural assessment (within 24 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transeptal Access
Time Frame: Intraprocedural assessment (within 24 hours)
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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)
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Intraprocedural assessment (within 24 hours)
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Plastic Shavings
Time Frame: Intraprocedural assessment of visible plastic shavings (within 24 hours)
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Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen
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Intraprocedural assessment of visible plastic shavings (within 24 hours)
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The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture
Time Frame: Acute peri-procedural complications will be defined as occurring within 30 days of ablation
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Events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture
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Acute peri-procedural complications will be defined as occurring within 30 days of ablation
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Transseptal time - septal engagement to sheath advancement
Time Frame: Intraprocedural assessment (measured in seconds)
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Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA
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Intraprocedural assessment (measured in seconds)
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Transseptal time - left atrial access to sheath positioning
Time Frame: Intraprocedural assessment (measured in seconds)
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Time from needle advancement through the septum to sheath advancement into the LA
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Intraprocedural assessment (measured in seconds)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6-May-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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