Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia - Full Text View

Sponsored by:	Biosense Webster, Inc.
Information provided by:	Biosense Webster, Inc.
ClinicalTrials.gov Identifier:	NCT00412607

Purpose

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	Device: NAVISTAR® THERMOCOOL® Catheter	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia

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

Estimated Enrollment:	249
Study Start Date:	January 2007

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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412607

Contacts

Contact: Call Center

866-788-3933

Locations

United States, Alabama
University of Alabama, Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Call Center 866-788-3933
Principal Investigator: Neal Kay, MD
United States, Arizona
Arizona Arrhythmia Consultants	Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Call Center 866-788-3933
Principal Investigator: Vijendra Swarup, MD
United States, California
Good Samaritan Hospital	Recruiting
Los Angeles, California, United States, 90017
Contact: Call Center 866-788-3933
Principal Investigator: Anil Bhandari, MD
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Call Center 886-788-3933
Principal Investigator: Henry Hsia, MD
United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Call Center 866-788-3933
Principal Investigator: John Beshai, MD
United States, Maryland
University of Maryland	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Call Center 866-788-3933
Principal Investigator: Timm Dickfeld, MD
United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Call Center 866-788-3933
Principal Investigator: William Stevenson, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Call Center 866-788-3933
Principal Investigator: Mark Josephson, MD
United States, Michigan
Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Contact: Call Center 866-788-3933
Principal Investigator: Claudio Schuger, MD
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Call Center 866-788-3933
Principal Investigator: Frank Bogun, MD
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Call Center 886-788-3933
Principal Investigator: Jennifer Cummings, MD
United States, Oklahoma
University of Oklahoma	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Call Center 866-788-3933
Principal Investigator: Karen Beckman, MD
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Call Center 866-788-3933
Principal Investigator: Francis Marchlinski, MD
Penn State University	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Mario Gonzalez, MD
Principal Investigator: Mario Gonzalez, MD
United States, Vermont
University of Vermont	Recruiting
Burlington, Vermont, United States, 05401
Contact: Call Center 866-788-3933
Principal Investigator: Peter Spector, MD

Sponsors and Collaborators

Biosense Webster, Inc.

More Information

No publications provided

Study ID Numbers:	BWI40036
Study First Received:	December 14, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00412607 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:

Ventricular Tachycardia
Heart Diseases
Arrhythmia

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia

Cardiovascular Diseases
Tachycardia, Ventricular
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009