Expired Study
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San Francisco, California 94143


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 .


Study summary:

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.


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


NCT ID:

NCT01209260


Primary Contact:

Principal Investigator
Gregory Marcus, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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