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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Baylis transseptal system group
Standard conventional transseptal group
Sponsored by
Jason Andrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring PVI Ablation, Cryoballoon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Paul's Hospital
  • Vancouver General Hospital, University of British Columbia
  • Queen Elizabeth II
  • Southlake Regional Health Centre
  • Université Laval
  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Baylis transseptal system group

Conventional transseptal group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Plastic Shavings
Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen
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
Transseptal time - septal engagement to sheath advancement
Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA
Transseptal time - left atrial access to sheath positioning
Time from needle advancement through the septum to sheath advancement into the LA

Full Information

First Posted
June 9, 2017
Last Updated
December 6, 2020
Sponsor
Jason Andrade
Collaborators
Baylis Medical Company
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1. Study Identification

Unique Protocol Identification Number
NCT03199703
Brief Title
Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation
Acronym
CRYO-LATS
Official Title
Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Andrade
Collaborators
Baylis Medical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
PVI Ablation, Cryoballoon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baylis transseptal system group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional transseptal group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Baylis transseptal system group
Intervention Type
Device
Intervention Name(s)
Standard conventional transseptal group
Primary Outcome Measure Information:
Title
Total time required for left atrial access
Description
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)
Secondary Outcome Measure Information:
Title
Transeptal Access
Description
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)
Title
Plastic Shavings
Description
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)
Title
The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture
Description
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
Title
Transseptal time - septal engagement to sheath advancement
Description
Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA
Time Frame
Intraprocedural assessment (measured in seconds)
Title
Transseptal time - left atrial access to sheath positioning
Description
Time from needle advancement through the septum to sheath advancement into the LA
Time Frame
Intraprocedural assessment (measured in seconds)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital, University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Queen Elizabeth II
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Université Laval
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35739438
Citation
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.
Results Reference
derived

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Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation

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