Clinical trial NCT01103661: Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
Official title: Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Longstanding Persistent Atrial Fibrillation
AF
Chronic AF
RF Ablation
nContact Surgical
Therapy Cool Path Ablation Catheter
St. Jude Medical
Lead sponsor: nContact Surgical Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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).

Primary outcomes:
measure: AF free, off all Class I and III Anti Arrhythmic Drugs (AADs)
timeFrame: 12 months
Secondary outcomes:
measure: AF free regardless of the Class I and III AADs status
timeFrame: 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: The Care Group, St Vincent Hospital
state: Indiana
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute, St. David's Hospital
state: Texas
city: Richmond
country: United States
facility: Cardiothoracic Surgical Associates, CJW Medical Center
state: Virginia
Study officials:
References: