Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation (CAP STOPS AF)
|ClinicalTrials.gov Identifier: NCT01103674|
Recruitment Status : Terminated (enrollment challenges, only one patient enrolled)
First Posted : April 15, 2010
Last Update Posted : April 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: Numeris®-AF Guided Coagulation System with VisiTrax®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||July 2012|
|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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Rodney Horton, MD||Texas Cardiac Arrhythmia Institute, St. David's Medical Center|