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nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Longstanding Persistent Atrial Fibrillation (AF)
This study is currently recruiting participants.
Verified June 2011 by nContact Surgical Inc.

First Received on July 29, 2009.   Last Updated on June 8, 2011   History of Changes
Sponsor: nContact Surgical Inc.
Information provided by: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT00950092
  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 longstanding persistent AF during concomitant cardiac surgery.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Longstanding Persistent Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Atrial Fibrillation
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 2014
Estimated Primary Completion Date: December 2012 (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 longstanding persistent Atrial Fibrillation(AF) or non self terminating AF, lasting greater than seven days but less than one year with at least one failed direct current(DC) cardioversion 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 longstanding persistent AF or non self-terminating AF, lasting greater than seven days but less than one year with at least one failed direct current (DC) cardioversion
  • 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
  • Documented history of untreated sleep apnea
  • Severe left ventricular hypertrophy - measured left ventricular wall thickness > 1.5 cm
  • History of coagulopathy
  • Previous cardiac surgery
  • Right ventricular outflow tract obstruction
  • History of pericarditis
  • Previous cerebrovascular accident (CVA)
  • Patients who have severe chronic obstructive pulmonary disease (COPD)
  • 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 arrhythmias other than AF
  • Patients who have had a previous catheter ablation for AF
  • 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, M.D., FACS            
Sub-Investigator: Mateo B. Dayo, M.D.            
United States, Oregon
Providence Heart and Vascular Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Michelle Dixon, CCRC     503-215-6746     michelle.dixon@providence.org    
Contact: Eric Johnson, CCRC     503-216-2075     eric.johnson@providence.org    
Principal Investigator: Charles Douville, MD, FACS            
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Charlotte Porter, R.N.     901-747-1262     charlotte@cvcclinic.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: Jagruti Vyas, Director of Clinical Studies, nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT00950092     History of Changes
Other Study ID Numbers: VAL-1116(A)
Study First Received: July 29, 2009
Last Updated: June 8, 2011
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, 2012



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