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

This study has been completed.
Sponsor:
Collaborator:
Baylis Medical Company
Information provided by (Responsible Party):
Gregory Marcus, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01209260
First received: September 9, 2010
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 .


Condition Intervention
Heart Diseases
 Device: Radiofrequency energy needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access (TRAVERSE-LA): A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Transseptal Access Procedure Time, in minutes. The specific time point that the outcome will be assessed is when left atrium access is obtained (from start of procedure). [ Time Frame: From beginning of transseptal procedure to the end (once left atrium is accessed), this will be on average, in minutes. ] [ Designated as safety issue: No ]
    We will be measuring in minutes and seconds the total amount of procedure time, from the beginning of the transseptal procedure until left atrium access is obtained in each patient. This will be on average, in minutes.


Secondary Outcome Measures:
  • Safety- 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, this will be up to 1 day after the procedure. ] [ Designated as safety issue: Yes ]
    • Aortic puncture
    • Epicardial puncture


Enrollment: 72
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiofrequency energy needle
Transseptal access using a radiofrequency energy needle
 Device: Radiofrequency energy needle
Comparison of a radiofrequency energy needle versus a mechanical needle for transseptal access
Other Names:
  • Baylis Medical Inc. transseptal needle
  • NRG RF transseptal needle
Active Comparator: Mechanical needle
Transseptal access using a mechanical (Brockenbrough) needle
 Device: Radiofrequency energy needle
Comparison of a radiofrequency energy needle versus a mechanical needle for transseptal access
Other Names:
  • Baylis Medical Inc. transseptal needle
  • NRG RF transseptal needle

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209260

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Baylis Medical Company
Investigators
Principal Investigator: Gregory Marcus, MD University of California, San Francisco
Principal Investigator: Jonathan Hsu, MD University of California, San Francisco
  More Information

Publications:

Responsible Party: Gregory Marcus, Associate Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01209260     History of Changes
Other Study ID Numbers: MarcusHsu
Study First Received: September 9, 2010
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Transseptal Puncture
Radiofrequency Energy
Left Atrium Access
Left Atrial Catheterization
Ablation
 Transseptal Catheterization
Electrocautery
Catheter Ablation
Atrial Fibrillation

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013