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
  Purpose

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.


Condition Intervention
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 LongStanding Persistent 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 ] [ 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 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.


Enrollment: 7
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: October 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 nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.

Detailed Description:

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.

  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)
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103661

Locations
United States, Indiana
The Care Group, St Vincent Hospital
Indianapolis, Indiana, United States, 46250
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
United States, Virginia
Cardiothoracic Surgical Associates, CJW Medical Center
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
nContact Surgical Inc.
  More Information

No publications provided

Responsible Party: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT01103661     History of Changes
Other Study ID Numbers: VAL-1140
Study First Received: April 13, 2010
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by nContact Surgical Inc.:
Longstanding Persistent Atrial Fibrillation
AF
Chronic AF
RF Ablation
nContact Surgical
Therapy Cool Path Ablation Catheter
St. Jude Medical

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

ClinicalTrials.gov processed this record on July 24, 2014