Ischemic, Ventricular Tachycardia
Conditions
Keywords
Ischemic, Ventricular Tachycardia, Implantable Cardioverter Defibrillators, Antiarrhythmic Drug Therapy, Ablation, Electrophysiology
Brief summary
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.
Interventions
DRUGDrug Treatment
Class I and III antiarrhythmic drug treatment.
DEVICECatheter Ablation
Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy) a. Subject must be on at least one AAD at time of enrollment 2. Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction 3. ICD implanted 4. 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator 5. History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction 6. 18 years or older 7. Able and willing to comply with all pre- and follow-up testing and requirements 8. Signed Informed Consent Form
Exclusion criteria
1. Age \< 18 years 2. Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram 3. Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours) 4. Contraindication to anticoagulation 5. NYHA class IV 6. Left ventricular assist devices (LVADs) or other circulatory assist devices 7. Stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as documented by electrocardiogram or cardiac imaging within the past three (3) months. (Note that a small cardiac enzyme release resulting from being in VT/shocks/etc. is not considered a myocardial infarction.) 8. Patients with active ischemia who are eligible for revascularization 9. Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy) 10. Other disease process likely to limit survival to less than 12 months 11. Serum creatinine of ≥ 2.5mg/dl 12. Thrombocytopenia or coagulopathy 13. Prior ablation for Ventricular Tachycardia 14. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 15. Enrollment in an study evaluating an investigational device or drug 16. Unable or unwilling to comply with protocol requirements 17. Exclusively Polymorphic Ventricular Tachycardia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events | From one month to 2 years follow up | The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure. |
| Cardiac-related Death | 2 years follow up | Subjects with cardiac-related death |
Countries
United States
Participant flow
Recruitment details
The first and the last subject were enrolled on July 9, 2012 and on January 30, 2014 respectively. All ASPIRE sites were notified that the study was terminated due to ongoing enrollment issues on March 10, 2014. A total of 21 US study sites were activated with 7 sites enrolling subjects. The last follow-up visit was completed on April 21, 2014.
Participants by arm
| Arm | Count |
|---|---|
| Catheter Ablation Group Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator. | 9 |
| Drug Treatment Group Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator. | 6 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Not Ablated | 2 | 0 |
| Overall Study | Not Meet Inclusion/Exclusion Criteria | 3 | 0 |
| Overall Study | Study Terminated by Sponsor | 3 | 4 |
Baseline characteristics
| Characteristic | Catheter Ablation Group | Total | Drug Treatment Group |
|---|---|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 14.4 | 66.1 years STANDARD_DEVIATION 11.7 | 63.3 years STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 12 Participants | 5 Participants |
| Region of Enrollment United States | 9 participants | 15 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 9 | 3 / 6 |
| serious Total, serious adverse events | 3 / 9 | 4 / 6 |
Outcome results
Primary
Cardiac-related Death
Subjects with cardiac-related death
Time frame: 2 years follow up
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation Group | Cardiac-related Death | 0 percentage of participants |
| Drug Treatment Group | Cardiac-related Death | 0 percentage of participants |
Primary
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.
Time frame: From one month to 2 years follow up
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation Group | Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events | 0 percentage of participants |
| Drug Treatment Group | Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events | 16.67 percentage of participants |