Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia (VT-CoA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Biosense Webster, Inc..
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Biosense Webster, Inc. Identifier:
First received: December 14, 2006
Last updated: September 8, 2011
Last verified: September 2011

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.

Condition Intervention Phase
Ventricular Tachycardia
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia

Resource links provided by NLM:

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Primary Outcome Measure [ Time Frame: 7 days and 1 year ] [ Designated as safety issue: Yes ]

    The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.

    The acute primary safety endpoint is the percentage of subjects experiencing cardiovascular-specific adverse events (CSAE) within 7 days of the ablation procedure.

Secondary Outcome Measures:
  • Secondary Outcome Measure [ Time Frame: Yearly ] [ Designated as safety issue: Yes ]
    Acute effectiveness, chronic effectiveness, pre/post assessment for hospitalization for heart failure, hospitalization for arrhythmia, ICD shocks (for subjects with implantable defibrillators), Ejection Fraction (EF), Quality of Life (QOL), and NYHA classification. Additionally, incidence of cardiac transplantation and mortality will be evaluated.

Estimated Enrollment: 249
Study Start Date: January 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NAVISTAR® THERMOCOOL® Catheter
    The primary objective is to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease
Detailed Description:

This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Four or more documented spontaneous episodes of sustained ventricular tachycardia, OR incessant VT (present 50% of the time with intervention for a period >12 h) refractory to medication and cardioversion due to prior myocardial infarction that have occurred in the last six months.
  • For patients with ICDs: Documented episodes must be four or greater for entry into the study.
  • For patients without ICDs: Documented episodes must be two or greater within two months and the assessment will be performed by a review of ECGs and hospitalization records
  • Failed therapy with an antiarrhythmic drug or ICD due to spontaneous recurrence of symptomatic ventricular tachycardia.
  • Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous 90 days.
  • Age 18 years or older.
  • Signed Patient Informed consent form
  • Able and willing to comply with all pre-, post-, and follow-up testing requirements

Exclusion Criteria:

  • Definite protruding left ventricular thrombus on pre-ablation echocardiogram.
  • Myocardial infarction within the preceding 2 months. Patients with incessant VT (present 50% of the time with intervention for a period >12 h) may be enrolled if their MI is at least 3 weeks old.
  • Patients with idiopathic VT.
  • Other disease process likely to limit survival to less than 12 months.
  • Class IV heart failure.
  • Serum creatinine of > 2.5 mg/dl.
  • Thrombocytopenia or coagulopathy.
  • Contraindication to heparin.
  • Women who are pregnant.
  • Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past 2 months. Patients with incessant VT (present 50% of the time with intervention for a period >12 h) may be enrolled if their surgery is at least 3 weeks old.
  • Acute illness or active systemic infection.
  • Unstable angina.
  • Severe aortic stenosis or flail mitral valve.
  • Uncontrolled heart failure.
  • Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study.
  • Enrolled in an investigational study evaluating another device or drug.
  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 identifier: NCT00412607

United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55902
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State University
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc. Identifier: NCT00412607     History of Changes
Other Study ID Numbers: BWI40036
Study First Received: December 14, 2006
Last Updated: September 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Ventricular Tachycardia
Heart Diseases

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 18, 2014