Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia (VT-CoA)

• ClinicalTrials.gov Identifier: NCT00412607
• Recruitment Status: Completed
• First Posted: December 18, 2006
• Results First Posted: October 16, 2014
• Last Update Posted: November 5, 2014
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia	Device: NAVISTAR® THERMOCOOL® Catheter	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 249 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
• Study Start Date: January 2007
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: NaviStar ThermoCool Catheter	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

Outcome Measures

Primary Outcome Measures :

1. The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. [ Time Frame: 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.
2. The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure. [ Time Frame: 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 :

1. Percentage of Subjects Achieved Acute Success [ Time Frame: 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.
2. Percentage of Subjects Who Achieved Chronic Effectiveness [ Time Frame: 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.
3. Number of Subjects Achieved Long-term Efficacy Success [ Time Frame: 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.
4. Change in Left Ventricular Ejection Fraction at 6 Month From Baseline [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama, Birmingham

Birmingham, Alabama, United States, 35294

United States, Arizona

Arizona Arrhythmia Consultants

Scottsdale, Arizona, United States, 85251

United States, California

Good Samaritan Hospital

Los Angeles, California, United States, 90017

Stanford University School of Medicine

Stanford, California, United States, 94305

United States, Florida

Florida Hospital

Orlando, Florida, United States, 32803

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital

Detroit, Michigan, United States, 48202

United States, Minnesota

Mayo Clinic Foundation

Rochester, Minnesota, United States, 55902

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Oklahoma

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

Penn State University

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Texas Cardiac Arrhythmia Research - St. David's

Austin, Texas, United States, 78705

United States, Vermont

University of Vermont

Burlington, Vermont, United States, 05401

Sponsors and Collaborators

Biosense Webster, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT00412607
• Other Study ID Numbers: BWI40036
• First Posted: December 18, 2006
• Results First Posted: October 16, 2014
• Last Update Posted: November 5, 2014
• Last Verified: October 2014

Keywords provided by Biosense Webster, Inc.:

Ventricular Tachycardia; Heart Diseases; Arrhythmia

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes