Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation

Atrial Fibrillation Clinical Trial

— CRYO-LATS  

Official title:

Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199703
• Other study ID #: 6-May-16
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 1, 2020
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Baylis transseptal system group

• Standard conventional transseptal group

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Jason Andrade	Baylis Medical Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Intraprocedural assessment (within 24 hours)
Secondary	Plastic Shavings	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)
Secondary	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	Acute peri-procedural complications will be defined as occurring within 30 days of ablation
Secondary	Transseptal time - septal engagement to sheath advancement	Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA	Intraprocedural assessment (measured in seconds)
Secondary	Transseptal time - left atrial access to sheath positioning	Time from needle advancement through the septum to sheath advancement into the LA	Intraprocedural assessment (measured in seconds)