Ventricular Tachycardia
Conditions
Keywords
Ventricular Tachycardia, Heart Diseases, Arrhythmia
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.
Interventions
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
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. | 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. |
| The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure. | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieved Acute Success | 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. |
| Percentage of Subjects Who Achieved Chronic Effectiveness | 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. |
| Number of Subjects Achieved Long-term Efficacy Success | 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. |
| Change in Left Ventricular Ejection Fraction at 6 Month From Baseline | 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. |
Participant flow
Recruitment details
The first subject was enrolled on April 3, 2007. Subject enrollment was completed on May 19, 2009 after reaching the minimum enrollment criteria of two hundred forty-nine (249) subjects. Subject follow-up was completed on June 8, 2012.
Participants by arm
| Arm | Count |
|---|---|
| NAVISTAR THERMOCOOL Catheter NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia. | 249 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 61 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Not meet inclusion/exclusion Criteria | 15 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | NAVISTAR THERMOCOOL Catheter |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 9.8 |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Black | 14 participants |
| Race/Ethnicity, Customized Caucasian | 229 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Region of Enrollment United States | 249 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 177 / 233 |
| serious Total, serious adverse events | 37 / 233 |
Outcome results
Primary
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.
Time frame: 12-month post ablation
Population: Safety analysis population - subjects who underwent insertion of the study catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR THERMOCOOL Catheter | The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. | 13.3 percentage of mortality |
Comparison: Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05.Fisher Exact
Primary
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.
Time frame: Seven days post ablation procedure
Population: Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR THERMOCOOL Catheter | The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure. | 4.3 percentage of Adverse Event |
Secondary
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.
Time frame: 6-month follow up
Population: Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NAVISTAR THERMOCOOL Catheter | Change in Left Ventricular Ejection Fraction at 6 Month From Baseline | Baseline (Pre-Ablation) | 30.6 percentage of blood leaving the heart | Standard Deviation 12.5 |
| NAVISTAR THERMOCOOL Catheter | Change in Left Ventricular Ejection Fraction at 6 Month From Baseline | 6-Month | 32.9 percentage of blood leaving the heart | Standard Deviation 11.53 |
| NAVISTAR THERMOCOOL Catheter | Change in Left Ventricular Ejection Fraction at 6 Month From Baseline | Change from Baseline | 0.9 percentage of blood leaving the heart | Standard Deviation 8.23 |
Secondary
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.
Time frame: 3-year follow up
Population: Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NAVISTAR THERMOCOOL Catheter | Number of Subjects Achieved Long-term Efficacy Success | 2-Year Follow-up | 161 participants |
| NAVISTAR THERMOCOOL Catheter | Number of Subjects Achieved Long-term Efficacy Success | 12-Month Follow-up | 176 participants |
| NAVISTAR THERMOCOOL Catheter | Number of Subjects Achieved Long-term Efficacy Success | 3-Year Follow-up | 141 participants |
| Reported Recurrence | Number of Subjects Achieved Long-term Efficacy Success | 2-Year Follow-up | 48 participants |
| Reported Recurrence | Number of Subjects Achieved Long-term Efficacy Success | 12-Month Follow-up | 40 participants |
| Reported Recurrence | Number of Subjects Achieved Long-term Efficacy Success | 3-Year Follow-up | 34 participants |
| Reported No Recurrence | Number of Subjects Achieved Long-term Efficacy Success | 12-Month Follow-up | 136 participants |
| Reported No Recurrence | Number of Subjects Achieved Long-term Efficacy Success | 3-Year Follow-up | 107 participants |
| Reported No Recurrence | Number of Subjects Achieved Long-term Efficacy Success | 2-Year Follow-up | 113 participants |
Secondary
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.
Time frame: Duration from post-procedure to hospital discharge, up to 2 days
Population: Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR THERMOCOOL Catheter | Percentage of Subjects Achieved Acute Success | 74.9 Percentage of participants |
Secondary
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.
Time frame: 6-month follow up
Population: Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR THERMOCOOL Catheter | Percentage of Subjects Who Achieved Chronic Effectiveness | 62.0 Percentage of participants |