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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Numeris-AF Tethered Coagulation System with VisiTrax
Sponsored by
nContact Surgical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring AF, atrial fibrillation, ablation, surgical ablation, afib, coagulation, RF, epicardial, Arrhythmias

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Venice Regional Medical Center
  • Baptist Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Outcomes

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.

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.
Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.

Full Information

First Posted
July 29, 2009
Last Updated
April 2, 2014
Sponsor
nContact Surgical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00950092
Brief Title
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
Official Title
Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
nContact Surgical Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AF, atrial fibrillation, ablation, surgical ablation, afib, coagulation, RF, epicardial, Arrhythmias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Numeris-AF Tethered Coagulation System with VisiTrax
Other Intervention Name(s)
RF Ablation, Coagulation of cardiac tissue, nContact Surgical
Intervention Description
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Garrett, M.D.
Organizational Affiliation
Baptist Memorial Hospital - Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Venice Regional Medical Center
City
Venice
State/Province
Florida
ZIP/Postal Code
34285-3298
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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