N/A N=72 Randomized Single-blind Treatment

Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

Heart Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01209260 ↗

Enrolled (actual)

Serious AEs

2.8%

Results posted

Jan 2014

Primary outcome: Primary: Transseptal Access Procedure Time — 2.3; 7.3 minutes — p=0.005

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Radiofrequency energy needle (Device); Mechanical Needle (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Transseptal Access Procedure Time	2.3; 7.3	0.005 sig
SECONDARY Number of Participants With Adverse Events as a Measure of Safety	1; 1	—
SECONDARY Performance of the Assigned Needle Type	36; 26; 0; 10	<0.001 sig
SECONDARY Plastic Dilator Shavings	0; 12	<0.001 sig

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 .

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01209260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.