Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation (CAPstopsLSPAF)

nContact Surgical

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01103661

VAL-1140

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

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)
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
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).