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

Primary Purpose

Ventricular Tachycardia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NAVISTAR® THERMOCOOL® Catheter
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular Tachycardia, Heart Diseases, Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama, Birmingham
  • Arizona Arrhythmia Consultants
  • Good Samaritan Hospital
  • Stanford University School of Medicine
  • Florida Hospital
  • University of Chicago
  • University of Maryland
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • Henry Ford Hospital
  • Mayo Clinic Foundation
  • Cleveland Clinic Foundation
  • University of Oklahoma
  • Penn State University
  • University of Pennsylvania
  • Texas Cardiac Arrhythmia Research - St. David's
  • University of Vermont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NaviStar ThermoCool Catheter

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 14, 2006
Last Updated
October 29, 2014
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00412607
Brief Title
Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia
Acronym
VT-CoA
Official Title
NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular Tachycardia, Heart Diseases, Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NaviStar ThermoCool Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NAVISTAR® THERMOCOOL® Catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
Description
The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.
Time Frame
12-month post ablation
Title
The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
Description
The acute primary safety endpoint is 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
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieved Acute Success
Description
Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.
Time Frame
Duration from post-procedure to hospital discharge, up to 2 days
Title
Percentage of Subjects Who Achieved Chronic Effectiveness
Description
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.
Time Frame
6-month follow up
Title
Number of Subjects Achieved Long-term Efficacy Success
Description
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.
Time Frame
3-year follow up
Title
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
Description
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.
Time Frame
6-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one) For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study. 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. 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). Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention. Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days. Age eighteen (18) years or older. Signed Patient Informed consent form. Able and willing to comply with all pre-, post-, and follow-up testing requirements. Exclusion Criteria: Definite protruding left ventricular thrombus on pre-ablation echocardiogram. 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. Patients with idiopathic VT. Other disease process likely to limit survival to less than twelve (12) months. Class IV heart failure. Serum creatinine of > 2.5 mg/dl. Thrombocytopenia (defined as platelet count <80,000) or coagulopathy. Contraindication to heparin. Women who are pregnant. 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. Acute illness or active systemic infection. Unstable angina. Severe aortic stenosis or flail mitral valve. Uncontrolled heart failure. Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study. Enrolled in an investigational study evaluating another device or drug.
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research - St. David's
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26868693
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.
Results Reference
derived

Learn more about this trial

Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

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