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Completed

NCT Number: NCT01209260

Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

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 .

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Key information

Conditions

Heart Diseases Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency energy needle

Device

Radiofrequency energy needle for transseptal access

Other names: Baylis Medical Inc. transseptal needle, NRG RF transseptal needle

Mechanical Needle

Device

Mechanical needle for transseptal access

Other names: Brockenbrough Needle

Primary outcomes

  1. Transseptal Access Procedure Time

    Time frame: Day of procedure

    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.

Secondary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety

    Time frame: During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.

  2. Performance of the Assigned Needle Type

    Time frame: at time of procedure

    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.

  3. Plastic Dilator Shavings

    Time frame: immediately prior to procedure

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Baylis Medical Company

Registry information

Official study title

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

Acronym: TRAVERSE-LA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2010
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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