Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Device: Radiofrequency energy needle; Device: Mechanical Needle

• Registration Number: NCT01209260
• Lead Sponsor: University of California, San Francisco

Brief 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 .

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 Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-27
• Study Start: 2010-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2013-12-05
• Results First Submitted QC: 2013-12-09
• Status Verified: 2014-01
• Results First Posted: 2014-01-28
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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Exclusion Criteria

• Patients unable to grant informed, written consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency energy needle	Radiofrequency energy needle	Radiofrequency energy needle for transseptal access
Mechanical needle	Mechanical Needle	Mechanical (Brockenbrough) needle for transseptal access

Primary Outcome Measures

Name	Time	Method
Transseptal Access Procedure Time	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 Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety	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	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.
Plastic Dilator Shavings	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States