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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00412607
First received: December 14, 2006
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Ventricular Tachycardia
Device: NAVISTAR® THERMOCOOL® Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. [ Time Frame: 12-month post ablation ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Seven days post ablation procedure ] [ Designated as safety issue: Yes ]
    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 Achievd Acute Success [ Time Frame: Duration from post-procedure to hospital discharge, up to 2 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6-month follow up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3-year follow up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    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.


Enrollment: 249
Study Start Date: January 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412607

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

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00412607     History of Changes
Other Study ID Numbers: BWI40036
Study First Received: December 14, 2006
Results First Received: September 23, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Ventricular Tachycardia
Heart Diseases
Arrhythmia

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014