CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 511 enrolled
Drug / intervention
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01585961
NCT01585961N/ACompleted
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NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population

Biosense Webster, Inc.·observational·Posted Apr 26, 2012·Updated Jan 26, 2015

In Brief

An observational study evaluating Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter) for Atrial Fibrillation and Paroxysmal Arrhythmia. Completed, enrolled 511 participants across 45 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Paroxysmal Arrhythmia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.2 years ago

Interventions

Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)device

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.