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
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
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
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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