Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
Condition: Ventricular Tachycardia; Ischemic
MeSH terms: Tachycardia; Tachycardia, Ventricular; Ischemia
Intervention: Drug Treatment; Catheter Ablation
Intervention description: Class I and III antiarrhythmic drug treatment.; Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ischemic; Ventricular Tachycardia; Implantable Cardioverter Defibrillators; Antiarrhythmic Drug Therapy; Ablation; Electrophysiology

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.
    

Eligibility criteria:

        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