Clinical trial NCT00412607: Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia
Official title: NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Keywords: Ventricular Tachycardia
Heart Diseases
Arrhythmia
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
timeFrame: 12-month post ablation
measure: The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
timeFrame: Seven days post ablation procedure
Secondary outcomes:
measure: Percentage of Subjects Achieved Acute Success
timeFrame: Duration from post-procedure to hospital discharge, up to 2 days
measure: Percentage of Subjects Who Achieved Chronic Effectiveness
timeFrame: 6-month follow up
measure: Number of Subjects Achieved Long-term Efficacy Success
timeFrame: 3-year follow up
measure: Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
timeFrame: 6-month follow up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.