Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- nContact Surgical Inc.
- Enrollment
- 7
- Locations
- 4
- 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 study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
Detailed Description
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years; \< 80 years
- •Left atrium less than or equal to 6.5 cm (TTE)
- •History of AF for less than or equal to 10 years
- •Provided written informed consent
- •Symptomatic longstanding persistent Atrial Fibrillation (AF).
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
- •History of pericarditis
- •Previous cerebrovascular accident (CVA), excluding fully resolved TIA
- •Patients who have active infection or sepsis
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)