Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation (CAP STOPS AF)

nContact Surgical

Status

Terminated

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Numeris®-AF Guided Coagulation System with VisiTrax®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01103674

VAL-1150

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).