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
  Purpose

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 Intervention
Atrial Fibrillation
Device: Numeris-AF Tethered Coagulation System with VisiTrax

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by nContact Surgical Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: October 2009
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950092

Locations
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.
Investigators
Principal Investigator: Edward Garrett, M.D. Baptist Memorial Hospital - Memphis
  More Information

No publications provided

Responsible Party: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT00950092     History of Changes
Other Study ID Numbers: VAL-1116(C)
Study First Received: July 29, 2009
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by nContact Surgical Inc.:
AF
atrial fibrillation
ablation
surgical ablation
afib
coagulation
RF
epicardial
Arrhythmias

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

ClinicalTrials.gov processed this record on October 20, 2014