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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01557842
First received: March 16, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Appropriate ICD shocks (>2) for the treatment of VT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Slow VT below ICD detection threshold leading to hospitalization or necessitates an increase in the AAD regimen and/or repeat ablation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • VT storm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hospitalization for VT-related causes/events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cardiac-related death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Ablation of a Control, or reablation of a Treatment subject post hospital discharge [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurrence of appropriate device therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of appropriate ICD shocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Total VT burden (episodes) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to first occurrence of hospitalization for cardiovascular causes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Occurrence of early onset (within seven (7) days of study ablation with the study catether) primary adverse events for the Catheter Ablation Group (Treatment) only [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Occurrence of primary adverse events which occur following randomization through end of study for both Treatment and Control Groups. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Occurrence of peri-procedural serious adverse events >7 days but ≤30 days from the date of ablation procedure (for subjects randomized to the Catheter Ablation Group (Treatment)) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: June 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Mount Sinai School of Medicine
Study Chair: David Wilber, MD Loyola University
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01557842     History of Changes
Other Study ID Numbers: ASPIRE
Study First Received: March 16, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014