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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Ventricular Tachycardia	Device: NAVISTAR® THERMOCOOL® Catheter	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	249 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
Study Start Date :	January 2007
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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 :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one)

   1. For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study.
   2. 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.
   3. 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).
2. Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention.
3. Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days.
4. Age eighteen (18) years or older.
5. Signed Patient Informed consent form.
6. Able and willing to comply with all pre-, post-, and follow-up testing requirements.

Exclusion Criteria:

1. Definite protruding left ventricular thrombus on pre-ablation echocardiogram.
2. 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.
3. Patients with idiopathic VT.
4. Other disease process likely to limit survival to less than twelve (12) months.
5. Class IV heart failure.
6. Serum creatinine of > 2.5 mg/dl.
7. Thrombocytopenia (defined as platelet count <80,000) or coagulopathy.
8. Contraindication to heparin.
9. Women who are pregnant.
10. 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.
11. Acute illness or active systemic infection.
12. Unstable angina.
13. Severe aortic stenosis or flail mitral valve.
14. Uncontrolled heart failure.
15. Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study.
16. Enrolled in an investigational study evaluating another device or drug.

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marchlinski FE, Haffajee CI, Beshai JF, Dickfeld TL, Gonzalez MD, Hsia HH, Schuger CD, Beckman KJ, Bogun FM, Pollak SJ, Bhandari AK. Long-Term Success of Irrigated Radiofrequency Catheter Ablation of Sustained Ventricular Tachycardia: Post-Approval THERMOCOOL VT Trial. J Am Coll Cardiol. 2016 Feb 16;67(6):674-683. doi: 10.1016/j.jacc.2015.11.041.

Responsible Party:	Biosense Webster, Inc.
ClinicalTrials.gov Identifier:	NCT00412607 History of Changes
Other Study ID Numbers:	BWI40036
First Posted:	December 18, 2006
Results First Posted:	October 16, 2014
Last Update Posted:	November 5, 2014
Last Verified:	October 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