Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- nContact Surgical Inc.
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
Time Frame: 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 Outcomes
- AF free regardless of the Class I and III AADs status(12 months)