Clinical trial NCT01103674: Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
Official title: Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Paroxysmal Atrial Fibrillation
AF
Atrial Fibrillation
RF ablation
Lead sponsor: nContact Surgical Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 1
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 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.

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
* 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).

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: 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
Study officials:
affiliation: Texas Cardiac Arrhythmia Institute, St. David's Medical Center
name: Rodney Horton, MD
role: PRINCIPAL_INVESTIGATOR
References: