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

January 28, 2014 updated by: University of California, San Francisco

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency energy needle
Radiofrequency energy needle for transseptal access
Device: Radiofrequency energy needle
Radiofrequency energy needle for transseptal access
Other Names:
  • Baylis Medical Inc. transseptal needle
  • NRG RF transseptal needle
Active Comparator: Mechanical needle
Mechanical (Brockenbrough) needle for transseptal access
Device: Mechanical Needle
Mechanical needle for transseptal access
Other Names:
  • Brockenbrough Needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
at time of procedure
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.
immediately prior to procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Baylis Medical Company

Investigators

  • Principal Investigator: Gregory Marcus, MD, University of California, San Francisco
  • Principal Investigator: Jonathan Hsu, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MarcusHsu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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