Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia (VT-CoA)
This study is ongoing, but not recruiting participants.
Sponsor:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00412607
First received: December 14, 2006
Last updated: September 8, 2011
Last verified: September 2011
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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 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:
Detailed Description:
-
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
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
Locations
| 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. |
| ClinicalTrials.gov 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 Arrhythmia |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013