Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Baylis transseptal system group
* Device: Standard conventional transseptal group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baylis transseptal system group<br>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<br> <br> |
| Active Comparator: Conventional transseptal group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PVI Ablation, Cryoballoon