Phase 4
N=249
Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia
Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT00412607 ↗Enrolled (actual)
249
Serious AEs
15.9%
Results posted
Oct 2014
Primary outcome: Primary: The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. — 13.3 percentage of mortality
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- NAVISTAR® THERMOCOOL® Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biosense Webster, Inc.
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. |
13.3 | — |
| PRIMARY The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure. |
4.3 | — |
| SECONDARY Percentage of Subjects Achieved Acute Success |
74.9 | — |
| SECONDARY Percentage of Subjects Who Achieved Chronic Effectiveness |
62.0 | — |
| SECONDARY Number of Subjects Achieved Long-term Efficacy Success |
176; 40; 136; 161; 48; 113 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction at 6 Month From Baseline |
30.6; 32.9; 0.9 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT00412607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.