Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation

NCT03199703 | Completed

• 1 other identifier: 6-May-16
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrial Fibrillation

Keywords

PVI Ablation; Cryoballoon

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraprocedural assessment (within 24 hours)

Secondary Outcomes (5)

• Transeptal Access

  Intraprocedural assessment (within 24 hours)

• Plastic Shavings

  Intraprocedural assessment of visible plastic shavings (within 24 hours)

• The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture

  Acute peri-procedural complications will be defined as occurring within 30 days of ablation

• Transseptal time - septal engagement to sheath advancement

  Intraprocedural assessment (measured in seconds)

• Transseptal time - left atrial access to sheath positioning

  Intraprocedural assessment (measured in seconds)

Study Arms (2)

Baylis transseptal system group

ACTIVE COMPARATOR

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

Conventional transseptal group

ACTIVE COMPARATOR

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

Interventions

Baylis transseptal system group DEVICE

Baylis transseptal system group

Standard conventional transseptal group DEVICE

Conventional transseptal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jason Andrade: lead
• Baylis Medical Company: collaborator

Study Sites (6)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital, University of British Columbia

Vancouver, British Columbia, Canada

Location

Queen Elizabeth II

Halifax, Nova Scotia, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

Université Laval

Québec, Quebec, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 35739438 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD FRCPC FHRS

Model Details: 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 27, 2017
• Study Start: January 17, 2017
• Primary Completion: May 17, 2019
• Study Completion: August 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

CA (6)