Clinical trial NCT00950092: nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
Official title: Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: AF
atrial fibrillation
ablation
surgical ablation
afib
coagulation
RF
epicardial
Arrhythmias
Lead sponsor: nContact Surgical Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-31
Enrollment: 5
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, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.

Detailed description: The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years; \< 80 years
* Left atrium =\< 6.0 cm
* Documented persistent or longstanding persistent AF
* History of AF =\< 10 years
* Scheduled for a concomitant cardiac procedure

  * Coronary bypass surgery (CABG)
  * Mitral valve repair/replacement
  * Aortic valve replacement
  * ASD repair
  * Tricuspid valve repair/replacement
  * Myxoma
  * Any combination of the above procedures
* Provided written informed consent

Exclusion Criteria:

* Left atrial size \> 6.0 cm (pre-op TTE - parasternal 4 chamber view)
* History of AF \> 10 years
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* History of coagulopathy
* Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA)
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
* Patients who are being treated for ventricular arrhythmias
* Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
* 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: The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.
timeFrame: 9 months
Secondary outcomes:
measure: Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.
timeFrame: 9 months
measure: Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.
timeFrame: 9 months
Other outcomes:
Locations:
city: Venice
country: United States
facility: Venice Regional Medical Center
state: Florida
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
Study officials:
affiliation: Baptist Memorial Hospital - Memphis
name: Edward Garrett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: