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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
nContact Surgical Inc.
ClinicalTrials.gov Identifier:
NCT00950092
First received: July 29, 2009
Last updated: April 2, 2014
Last verified: September 2013

July 29, 2009
April 2, 2014
October 2009
June 2013   (final data collection date for primary outcome 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. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00950092 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
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
Treatment
Intervention: Device: Numeris-AF Tethered Coagulation System with VisiTrax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
October 2013
June 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00950092
VAL-1116(C)
Yes
nContact Surgical Inc.
nContact Surgical Inc.
Not Provided
Principal Investigator: Edward Garrett, M.D. Baptist Memorial Hospital - Memphis
nContact Surgical Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP