Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation

Not Applicable

Terminated

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Numeris®-AF Guided Coagulation System with VisiTrax®

• Registration Number: NCT01103674
• Lead Sponsor: nContact Surgical Inc.

Brief Summary

This is a multi-center, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.

Detailed Description

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Primary Completion: 2012-03
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Age > 18 years; < 80 years
• Left atrium less than or equal to 6.5 cm (TTE)
• Symptomatic paroxysmal AF
• Provided written informed consent
• Refractory to at least one AAD (class I, II, III or IV)

Exclusion Criteria

• Patients requiring concomitant surgery
• Left ventricular ejection fraction < 30%
• Pregnant or planning to become pregnant during study
• Co-morbid medical conditions that limit one year life expectancy
• Measured left ventricular wall thickness > 1.5 cm
• History of coagulopathy
• Previous cardiac surgery
• Right ventricular outflow tract obstruction
• History of pericarditis
• Previous cerebrovascular accident (CVA), excluding fully resolved TIA
• Patients who have severe chronic obstructive pulmonary disease (COPD)
• Patients who have an active infection or sepsis
• Patients who have uncorrected reversible cause(s) of AF
• Patients who are contraindicated for anticoagulants
• Patients who are being treated for arrhythmias other than AF
• Patients who have had any previous AF or left atrial catheter ablation
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
• Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Numeris-AF Guided Coagulation System	Numeris®-AF Guided Coagulation System with VisiTrax®	-

Primary Outcome Measures

Name	Time	Method
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).	12 months	The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.

Secondary Outcome Measures

Name	Time	Method
AF free regardless of the Class I and III AADs status	12 months	The secondary efficacy data will be an evaluation of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure.

Trial Locations

Locations (2)

Texas Cardiac Arrhythmia Institute, St. David's Hospital; 🇺🇸 Austin, Texas, United States

Baptist Memorial Hospital; 🇺🇸 Memphis, Tennessee, United States