NCT01585961

NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 511 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Detailed description

This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

Conditions

• Atrial Fibrillation
• Paroxysmal Arrhythmia

Interventions

Type	Name	Description
DEVICE	Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)	Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-04-26
• Last updated: 2015-01-26
• Results posted: 2015-01-26

Locations

45 sites across 1 country: United States