nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: Numeris-AF Tethered Coagulation System with VisiTrax

• Registration Number: NCT00950092
• Lead Sponsor: nContact Surgical Inc.

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.

Study Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Study Start: 2009-10
• Primary Completion: 2013-06
• Status Verified: 2013-09
• Study Completion: 2013-10
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Numeris-AF Tethered Coagulation System with VisiTrax	-

Primary Outcome Measures

Name	Time	Method
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.	9 months

Secondary Outcome Measures

Name	Time	Method
Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.	9 months
Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.	9 months

Trial Locations

Locations (2)

Baptist Memorial Hospital; 🇺🇸 Memphis, Tennessee, United States

Venice Regional Medical Center; 🇺🇸 Venice, Florida, United States