Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators (ASPIRE)

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.

Study Overview

• Status: Terminated
• Conditions: Ventricular Tachycardia; Ischemic
• Intervention / Treatment: Device: Catheter Ablation; Drug: Drug Treatment

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Denver
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02199
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10032
      • Columbia University- New York Presbyterian Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group; This group receives radiofrequency catheter ablation and drug treatment.	Device: Catheter Ablation; Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
Experimental: Control Group; This group receives only drug treatment.	Drug: Drug Treatment; Class I and III antiarrhythmic drug treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From one month to 2 years follow up
Cardiac-related Death	Subjects with cardiac-related death	2 years follow up

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Chair: David Callans, MD, University of Pennsylvania; Study Chair: Francis Marchlinski, MD, University of Pennsylvania; Study Chair: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation; Study Chair: David Wilber, MD, Loyola University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): March 19, 2014
• Study Completion (Actual): March 19, 2014

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: May 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Ischemic; Ablation; Ventricular Tachycardia; Electrophysiology; Antiarrhythmic Drug Therapy; Implantable Cardioverter Defibrillators
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ischemia; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: ASPIRE