Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2010
End Date:December 2012
Contact:Jonathan Hsu, MD
Email:jhsu@medicine.ucsf.edu
Phone:415-443-2770

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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.

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
We found this trial at
1
site
500 Parnassus Ave
San Francisco, California 94110
(415) 476-9000
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