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Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation (CAP STOPS AF)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
nContact Surgical Inc.
ClinicalTrials.gov Identifier:
NCT01103674
First received: April 13, 2010
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Paroxysmal Atrial Fibrillation
 Device: Numeris®-AF Guided 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: Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by nContact Surgical Inc.:

Primary Outcome Measures:
  • AF free off all Class I and III Anti Arrhythmic Drugs (AADs). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Numeris-AF Guided Coagulation System Device: Numeris®-AF Guided Coagulation System with VisiTrax®
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.

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.

  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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103674

Locations
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Cardiac Arrhythmia Institute, St. David's Hospital
Austin, Texas, United States, 78705
Sponsors and Collaborators
nContact Surgical Inc.
Investigators
Principal Investigator: Rodney Horton, MD Texas Cardiac Arrhythmia Institute, St. David's Medical Center
  More Information

No publications provided

Responsible Party: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT01103674     History of Changes
Other Study ID Numbers: VAL-1150
Study First Received: April 13, 2010
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by nContact Surgical Inc.:
Paroxysmal Atrial Fibrillation
AF
Atrial Fibrillation
RF ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013