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Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation (CAPstopsLSPAF)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
nContact Surgical Inc.
ClinicalTrials.gov Identifier:
NCT01103661
First received: April 13, 2010
Last updated: April 2, 2014
Last verified: April 2013

April 13, 2010
April 2, 2014
April 2010
October 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01103661 on ClinicalTrials.gov Archive Site
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 assessment 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation

This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: Numeris®-AF Guided Coagulation System with VisiTrax®
Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.
Numeris-AF Guided Coagulation System
Intervention: Device: Numeris®-AF Guided Coagulation System with VisiTrax®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
April 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years; < 80 years
  • Left atrium less than or equal to 6.5 cm (TTE)
  • History of AF for less than or equal to 10 years
  • Provided written informed consent
  • Symptomatic longstanding persistent Atrial Fibrillation (AF).

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
  • History of pericarditis
  • Previous cerebrovascular accident (CVA), excluding fully resolved TIA
  • Patients who have 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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01103661
VAL-1140
Yes
nContact Surgical Inc.
nContact Surgical Inc.
Not Provided
Not Provided
nContact Surgical Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP