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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557842
First Posted: March 20, 2012
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biosense Webster, Inc.
  Purpose
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.

Condition Intervention Phase
Ventricular Tachycardia Ischemic Drug: Drug Treatment Device: Catheter Ablation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events [ Time Frame: 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 [ Time Frame: 2 years follow up ]
    Subjects with cardiac-related death


Enrollment: 15
Actual Study Start Date: June 1, 2012
Study Completion Date: March 19, 2014
Primary Completion Date: March 19, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557842


  Show 23 Study Locations
Sponsors and Collaborators
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: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
Study Chair: David Wilber, MD Loyola University
  More Information

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01557842     History of Changes
Other Study ID Numbers: ASPIRE
First Submitted: March 16, 2012
First Posted: March 20, 2012
Results First Submitted: December 19, 2014
Results First Posted: January 1, 2015
Last Update Posted: June 8, 2017
Last Verified: May 2017

Keywords provided by Biosense Webster, Inc.:
Ischemic
Ventricular Tachycardia
Implantable Cardioverter Defibrillators
Antiarrhythmic Drug Therapy
Ablation
Electrophysiology

Additional relevant MeSH terms:
Ischemia
Tachycardia
Tachycardia, Ventricular
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents