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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00950092
Recruitment Status : Terminated
First Posted : July 31, 2009
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Numeris-AF Tethered Coagulation System with VisiTrax

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
Study Start Date : October 2009
Primary Completion Date : June 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Treatment Device: Numeris-AF Tethered Coagulation System with VisiTrax
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
Other Names:
  • RF Ablation
  • Coagulation of cardiac tissue
  • nContact Surgical

Primary Outcome Measures :
  1. 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. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure. [ Time Frame: 9 months ]
  2. Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs. [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950092

United States, Florida
Venice Regional Medical Center
Venice, Florida, United States, 34285-3298
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
nContact Surgical Inc.
Principal Investigator: Edward Garrett, M.D. Baptist Memorial Hospital - Memphis

Responsible Party: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT00950092     History of Changes
Other Study ID Numbers: VAL-1116(C)
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: September 2013

Keywords provided by nContact Surgical Inc.:
atrial fibrillation
surgical ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes