Heart Diseases Clinical Trial
Official title:
Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access (TRAVERSE-LA): A Randomized Controlled Trial
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 .
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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