Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

Phase 4

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Device: NAVISTAR® THERMOCOOL® Catheter

• Registration Number: NCT00412607
• Lead Sponsor: Biosense Webster, Inc.

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.

Study Timeline

• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-18
• Study Start: 2007-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-09-23
• Results First Submitted QC: 2014-10-14
• Results First Posted: 2014-10-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NaviStar ThermoCool Catheter	NAVISTAR® THERMOCOOL® Catheter	-

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.	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.	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

Name	Time	Method
Number of Subjects Achieved Long-term Efficacy Success	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.
Percentage of Subjects Achieved Acute Success	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.
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline	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.
Percentage of Subjects Who Achieved Chronic Effectiveness	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.

Trial Locations

Locations (18)

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Arizona Arrhythmia Consultants; 🇺🇸 Scottsdale, Arizona, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Cardiac Arrhythmia Research - St. David's; 🇺🇸 Austin, Texas, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Penn State University; 🇺🇸 Hershey, Pennsylvania, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic Foundation; 🇺🇸 Rochester, Minnesota, United States