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

December 6, 2020 updated by: Jason Andrade

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

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

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital, University of British Columbia
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II
    • Ontario
      • Newmarket, Ontario, Canada
        • Southlake Regional Health Centre
    • Quebec
      • Quebec City, Quebec, Canada
        • Université Laval
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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)
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.
Intraprocedural assessment (within 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Intraprocedural assessment (within 24 hours)
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
Intraprocedural assessment of visible plastic shavings (within 24 hours)
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
Acute peri-procedural complications will be defined as occurring within 30 days of ablation
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
Intraprocedural assessment (measured in seconds)
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
Intraprocedural assessment (measured in seconds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Actual)

May 17, 2019

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 6-May-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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