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Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation (CRYO-LATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199703
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Baylis Medical Company
Information provided by (Responsible Party):
Jason Andrade, University of British Columbia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Baylis transseptal system group Device: Standard conventional transseptal group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : January 17, 2020
Estimated Study Completion Date : August 17, 2020

Resource links provided by the National Library of Medicine


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.
Device: Baylis transseptal system group
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.
Device: Standard conventional transseptal group



Primary Outcome Measures :
  1. Total time required for left atrial access [ Time Frame: Intraprocedural assessment (within 24 hours) ]
    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.


Secondary Outcome Measures :
  1. Transeptal Access [ Time Frame: Intraprocedural assessment (within 24 hours) ]
    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)

  2. Plastic Shavings [ Time Frame: Intraprocedural assessment of visible plastic shavings (within 24 hours) ]
    Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen

  3. 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 ]
    Events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture

  4. Transseptal time - septal engagement to sheath advancement [ Time Frame: Intraprocedural assessment (measured in seconds) ]
    Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA

  5. Transseptal time - left atrial access to sheath positioning [ Time Frame: Intraprocedural assessment (measured in seconds) ]
    Time from needle advancement through the septum to sheath advancement into the LA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199703


Locations
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Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Dr. Zachary Laksman, MD       zlaksman@mail.ubc.ca   
Vancouver General Hospital, University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Dr. Jason Andrade, MD       jason.andrade@vch.ca   
Canada, Nova Scotia
Queen Elizabeth II Recruiting
Halifax, Nova Scotia, Canada
Contact: Dr. John Sapp, MD       john.sapp@nshealth.ca   
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Contact: Dr. Atul Verma, MD       atul.verma@utoronto.ca   
Canada, Quebec
Université Laval Recruiting
Quebec City, Quebec, Canada
Contact: Dr. Jean Champagne       Jean.Champagne@fmed.ulaval.ca   
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Dr Stephan Wardell       sww375@mail.usask.ca   
Sponsors and Collaborators
Jason Andrade
Baylis Medical Company

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Responsible Party: Jason Andrade, MD FRCPC FHRS, University of British Columbia
ClinicalTrials.gov Identifier: NCT03199703    
Other Study ID Numbers: 6-May-16
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Andrade, University of British Columbia:
PVI Ablation
Cryoballoon
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes