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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.
(enrollment challenges, only one patient enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103674
First Posted: April 15, 2010
Last Update Posted: April 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
nContact Surgical Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]
    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 ]
    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
Study Completion Date: July 2012
Primary Completion Date: March 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT01103674     History of Changes
Other Study ID Numbers: VAL-1150
First Submitted: April 13, 2010
First Posted: April 15, 2010
Last Update Posted: April 3, 2014
Last Verified: July 2012

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