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Heart DiseasesTRAVERSE-LANCT01209260

Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

A study testing Radiofrequency energy needle and Mechanical Needle in people with Heart Diseases, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Diseases
What is being tested?
Radiofrequency energy needle and Mechanical Needle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
Nov 2010to Nov 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing radiofrequency ablation within the left atrium through a transseptal approach
  • Patients greater than 18 years of age

Who cannot join

  • Patients unable to grant informed, written consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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 .

Read the 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.

Conditions
Heart Diseases
Being tested
Radiofrequency energy needle, Mechanical Needle
Keywords
Transseptal Puncture, Radiofrequency Energy, Left Atrium Access, Left Atrial Catheterization, Ablation, Transseptal Catheterization, Electrocautery, Catheter Ablation, Atrial Fibrillation
Medical subject headings
Heart Diseases, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency energy needleDevice

    Also called Baylis Medical Inc. transseptal needle, NRG RF transseptal needle

    Radiofrequency energy needle for transseptal access

  • Mechanical NeedleDevice

    Also called Brockenbrough Needle

    Mechanical needle for transseptal access

Study groups in NCT01209260
Study groupRoleWhat they receive
Radiofrequency energy needleExperimentalRadiofrequency energy needle for transseptal access
Receives: Device: Radiofrequency energy needle
Mechanical needleActive comparatorMechanical (Brockenbrough) needle for transseptal access
Receives: Device: Mechanical Needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transseptal Access Procedure Time

    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.

    Measured: Day of procedure

Secondary outcomes (3)

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

    Measured: 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

    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.

    Measured: at time of procedure

  3. Plastic Dilator Shavings

    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.

    Measured: immediately prior to procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01209260
Sponsor's protocol ID
MarcusHsu
Acronym
TRAVERSE-LA
Status last verified
Jan 2014
First submitted
9 Sep 2010
Last updated
28 Feb 2014
Data monitoring committee
No

Publications

  • ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.

    PubMed 13649591

  • B-Lundqvist C, Olsson SB, Varnauskas E. Transseptal left heart catheterization: a review of 278 studies. Clin Cardiol. 1986 Jan;9(1):21-6. doi: 10.1002/clc.4960090105.

    PubMed 3943231

  • Roelke M, Smith AJ, Palacios IF. The technique and safety of transseptal left heart catheterization: the Massachusetts General Hospital experience with 1,279 procedures. Cathet Cardiovasc Diagn. 1994 Aug;32(4):332-9. doi: 10.1002/ccd.1810320409.

    PubMed 7987913

  • De Ponti R, Cappato R, Curnis A, Della Bella P, Padeletti L, Raviele A, Santini M, Salerno-Uriarte JA. Trans-septal catheterization in the electrophysiology laboratory: data from a multicenter survey spanning 12 years. J Am Coll Cardiol. 2006 Mar 7;47(5):1037-42. doi: 10.1016/j.jacc.2005.10.046. Epub 2006 Feb 9.

    PubMed 16516090

  • Bidart C, Vaseghi M, Cesario DA, Mahajan A, Fujimura O, Boyle NG, Shivkumar K. Radiofrequency current delivery via transseptal needle to facilitate septal puncture. Heart Rhythm. 2007 Dec;4(12):1573-6. doi: 10.1016/j.hrthm.2007.07.008. Epub 2007 Jul 14. No abstract available.

    PubMed 17997362

  • Justino H, Benson LN, Nykanen DG. Transcatheter creation of an atrial septal defect using radiofrequency perforation. Catheter Cardiovasc Interv. 2001 Sep;54(1):83-7. doi: 10.1002/ccd.1244.

    PubMed 11553955

  • Smelley MP, Shah DP, Weisberg I, Kim SS, Lin AC, Beshai JF, Burke MC, Knight BP. Initial experience using a radiofrequency powered transseptal needle. J Cardiovasc Electrophysiol. 2010 Apr;21(4):423-7. doi: 10.1111/j.1540-8167.2009.01656.x. Epub 2009 Nov 17.

    PubMed 19925604

  • Sakata Y, Feldman T. Transcatheter creation of atrial septal perforation using a radiofrequency transseptal system: novel approach as an alternative to transseptal needle puncture. Catheter Cardiovasc Interv. 2005 Mar;64(3):327-32. doi: 10.1002/ccd.20284.

    PubMed 15736263

  • Crystal MA, Mirza MA, Benson LN. A radiofrequency transseptal needle: initial animal studies. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):769-73. doi: 10.1002/ccd.22600.

    PubMed 20506170

  • Hsu JC, Badhwar N, Gerstenfeld EP, Lee RJ, Mandyam MC, Dewland TA, Imburgia KE, Hoffmayer KS, Vedantham V, Lee BK, Tseng ZH, Scheinman MM, Olgin JE, Marcus GM. Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study). J Am Heart Assoc. 2013 Sep 17;2(5):e000428. doi: 10.1161/JAHA.113.000428.

    PubMed 24045120

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency energy needle and Mechanical Needle in people with Heart Diseases, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transseptal Access Procedure Time (time frame: Day of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01209260, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.

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