Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: NAVISTAR® THERMOCOOL® Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaviStar ThermoCool Catheter<br> | Device: NAVISTAR® THERMOCOOL® Catheter<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. | The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation. | 12-month post ablation | 
| The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the 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. | Seven days post ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieved Acute Success | Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge. | Duration from post-procedure to hospital discharge, up to 2 days | 
| Percentage of Subjects Who Achieved Chronic Effectiveness | 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. | 6-month follow up | 
| Number of Subjects Achieved Long-term Efficacy Success | 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. | 3-year follow up | 
| Change in Left Ventricular Ejection Fraction at 6 Month From Baseline | 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. | 6-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Tachycardia, Heart Diseases, Arrhythmia