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):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01209260
First received: September 9, 2010
Last updated: January 28, 2014
Last verified: January 2014
  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
Device: Mechanical 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:


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

Primary Outcome Measures:
  • Transseptal Access Procedure Time [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Performance of the Assigned Needle Type [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    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.

  • Plastic Dilator Shavings [ Time Frame: immediately prior to procedure ] [ Designated as safety issue: Yes ]
    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.


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
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 Name: Brockenbrough 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01209260     History of Changes
Other Study ID Numbers: MarcusHsu
Study First Received: September 9, 2010
Results First Received: December 5, 2013
Last Updated: January 28, 2014
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 October 01, 2014