Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation (CAP STOPS AF)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Numeris®-AF Guided Coagulation System with VisiTrax®
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, AF, Atrial Fibrillation, RF ablation
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years; < 80 years
- Left atrium less than or equal to 6.5 cm (TTE)
- Symptomatic paroxysmal AF
- Provided written informed consent
- Refractory to at least one AAD (class I, II, III or IV)
Exclusion Criteria:
- Patients requiring concomitant surgery
- Left ventricular ejection fraction < 30%
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- 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), excluding fully resolved TIA
- Patients who have severe chronic obstructive pulmonary disease (COPD)
- Patients who have an active infection or sepsis
- Patients who have uncorrected reversible cause(s) of AF
- Patients who are contraindicated for anticoagulants
- Patients who are being treated for arrhythmias other than AF
- Patients who have had any previous AF or left atrial catheter ablation
- 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
- Baptist Memorial Hospital
- Texas Cardiac Arrhythmia Institute, St. David's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Numeris-AF Guided Coagulation System
Arm Description
Outcomes
Primary Outcome Measures
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.
Secondary Outcome Measures
AF free regardless of the Class I and III AADs status
The secondary efficacy data will be an evaluation of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01103674
Brief Title
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
Acronym
CAP STOPS AF
Official Title
Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
enrollment challenges, only one patient enrolled
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (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, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.
Detailed Description
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, AF, Atrial Fibrillation, RF ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Numeris-AF Guided Coagulation System
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Numeris®-AF Guided Coagulation System with VisiTrax®
Intervention Description
Combined epicardial / endocardial procedure using the Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster ThermoCool Catheter in conjunction with the Carto Navigation System endocardially.
Primary Outcome Measure Information:
Title
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
Description
The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
AF free regardless of the Class I and III AADs status
Description
The secondary efficacy data will be an evaluation of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure.
Time Frame
12 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 less than or equal to 6.5 cm (TTE)
Symptomatic paroxysmal AF
Provided written informed consent
Refractory to at least one AAD (class I, II, III or IV)
Exclusion Criteria:
Patients requiring concomitant surgery
Left ventricular ejection fraction < 30%
Pregnant or planning to become pregnant during study
Co-morbid medical conditions that limit one year life expectancy
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), excluding fully resolved TIA
Patients who have severe chronic obstructive pulmonary disease (COPD)
Patients who have an active infection or sepsis
Patients who have uncorrected reversible cause(s) of AF
Patients who are contraindicated for anticoagulants
Patients who are being treated for arrhythmias other than AF
Patients who have had any previous AF or left atrial catheter ablation
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
Rodney Horton, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Cardiac Arrhythmia Institute, St. David's Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
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