Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

NCT ID: NCT00412607

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NaviStar ThermoCool Catheter

Group Type: EXPERIMENTAL

NAVISTAR® THERMOCOOL® Catheter

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 26868693 (View on PubMed)

Other Identifiers

BWI40036

Identifier Type: -

Identifier Source: org_study_id