Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

Study Overview
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Brief Summary
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This is a randomized controlled trial examining whether a mechanical needle versus a needle that uses radiofrequency energy is better at puncturing through a thin wall in the heart (called transseptal puncture) as measured by procedure time, during an electrical procedure/study of the heart .

Detailed Description
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Transseptal puncture is a commonly performed procedure allowing access to the left atrium for catheter ablation. Historically, a conventional Brockenbrough needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature.1, 2 Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.3, 4 Previous studies have evaluated the feasibility and safety of radiofrequency (RF) energy applied to a conventional needle as a technique to access the left atrium, particularly in patients with a repeat procedure, fibrotic septum or aneurysmal septum.5, 6 As a result of this earlier work, a special proprietary device has been designed. The NRG RF needle (Baylis Medical Inc., Montreal, Canada), uses radiofrequency energy emitted from the needle tip to aid in transseptal access. Despite limited literature to support its superiority and safety7-9compared to the conventional approach, the new device has become adopted in some electrophysiology procedures involving a transseptal puncture.

Official Title
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Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access (TRAVERSE-LA): A Randomized Controlled Trial

Conditions
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Heart Diseases

Intervention / Treatment
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* Device: Radiofrequency energy needle
* Device: Mechanical Needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing radiofrequency ablation within the left atrium through a transseptal approach Patients greater than 18 years of age Exclusion Criteria: Patients unable to grant informed, written consent

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency energy needle<br>Radiofrequency energy needle for transseptal access | Device: Radiofrequency energy needle<br>* Radiofrequency energy needle for transseptal access<br>* Other names: NRG RF transseptal needle;|
| Active Comparator: Mechanical needle<br>Mechanical (Brockenbrough) needle for transseptal access | Device: Mechanical Needle<br>* Mechanical needle for transseptal access<br>* Other names: Brockenbrough Needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transseptal Access Procedure Time | Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis. | Day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety |  | During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure. | 
| Performance of the Assigned Needle Type | Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall. | at time of procedure | 
| Plastic Dilator Shavings | In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded. | immediately prior to procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transseptal Puncture, Radiofrequency Energy, Left Atrium Access, Left Atrial Catheterization, Ablation, Transseptal Catheterization, Electrocautery, Catheter Ablation, Atrial Fibrillation