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

This study is currently recruiting participants.
Verified April 2013 by nContact Surgical Inc.
Sponsor:
Information provided by (Responsible Party):
nContact Surgical Inc.
ClinicalTrials.gov Identifier:
NCT00950092
First received: July 29, 2009
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 107
Study Start Date: October 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950092

Contacts
Contact: Jagruti Vyas, BS (MT) 919-655-1354 jvyas@ncontactsurgical.com
Contact: Jim Whayne, MS 919-655-1561 jwhayne@ncontactsurgical.com

Locations
United States, Florida
Venice Regional Medical Center Recruiting
Venice, Florida, United States, 34285-3298
Contact: Sharon Cleveland, RN, MSN, CCRN     941-483-7863     sharon.cleveland@vrmc.hma.com    
Contact: Jonathan Fong, MD     941-484-8004        
Principal Investigator: Jonathan C Fong, MD FACS            
Sub-Investigator: Mateo B. Dayo, M.D.            
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amber Kirby, RN     901-747-1268     amber@cvsclinic.com    
Contact: Charlotte Porter, RN     901-747-1262     charlotte@cvsclinic.com    
Principal Investigator: Edward Garrett, M.D.            
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 22, 2013
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013