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Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia (VT-CoA)
This study has been completed.
Sponsor:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00412607
First received: December 14, 2006
Last updated: October 29, 2014
Last verified: October 2014
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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 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:
- The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. [ Time Frame: 12-month post ablation ]The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.
- The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure. [ Time Frame: Seven days post ablation procedure ]The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.
Secondary Outcome Measures:
- Percentage of Subjects Achieved Acute Success [ Time Frame: Duration from post-procedure to hospital discharge, up to 2 days ]Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.
- Percentage of Subjects Who Achieved Chronic Effectiveness [ Time Frame: 6-month follow up ]Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.
- Number of Subjects Achieved Long-term Efficacy Success [ Time Frame: 3-year follow up ]Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.
- Change in Left Ventricular Ejection Fraction at 6 Month From Baseline [ Time Frame: 6-month follow up ]Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.
| Enrollment: | 249 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NaviStar ThermoCool Catheter |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one)
- For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study.
- For patients without ICDs: Documented episodes must be two (2) or greater within two (2) months and the assessment will be performed by a review of ECGs and hospitalization records.
- Incessant VT due to prior myocardial infarction (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion).
- Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention.
- Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days.
- Age eighteen (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 two (2) months. Patients with incessant VT (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion) may be enrolled if their MI is at least three (3) weeks old.
- Patients with idiopathic VT.
- Other disease process likely to limit survival to less than twelve (12) months.
- Class IV heart failure.
- Serum creatinine of > 2.5 mg/dl.
- Thrombocytopenia (defined as platelet count <80,000) or coagulopathy.
- Contraindication to heparin.
- Women who are pregnant.
- Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past two (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 three (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
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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: NCT00412607
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, Texas | |
| Texas Cardiac Arrhythmia Research - St. David's | |
| Austin, Texas, United States, 78705 | |
| United States, Vermont | |
| University of Vermont | |
| Burlington, Vermont, United States, 05401 | |
Sponsors and Collaborators
Biosense Webster, Inc.
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biosense Webster, Inc. |
| ClinicalTrials.gov Identifier: | NCT00412607 History of Changes |
| Other Study ID Numbers: |
BWI40036 |
| Study First Received: | December 14, 2006 |
| Results First Received: | September 23, 2014 |
| Last Updated: | October 29, 2014 |
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 July 21, 2017