Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— VT-CoA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412607
• Other study ID #: BWI40036
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2006
• Last updated: October 29, 2014
• Start date: January 2007
• Est. completion date: June 2012

Study information

• Verified date: October 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Texas Cardiac Arrhythmia Research - St. David's	Austin	Texas
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
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	Penn State University	Hershey	Pennsylvania
United States	Good Samaritan Hospital	Los Angeles	California
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Foundation	Rochester	Minnesota
United States	Arizona Arrhythmia Consultants	Scottsdale	Arizona
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No