Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access (TRAVERSE-LA)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Heart Diseases

Treatments: Device: Mechanical Needle; Device: Radiofrequency energy needle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01209260

MarcusHsu

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Radiofrequency energy needle

Experimental group

Description:

Radiofrequency energy needle for transseptal access

Treatment:

Device: Radiofrequency energy needle

Mechanical needle

Active Comparator group

Description:

Mechanical (Brockenbrough) needle for transseptal access

Treatment:

Device: Mechanical Needle