Back to resultsEarly Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators (ASPIRE)
Primary Purpose
Ventricular Tachycardia, Ischemic
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Drug Treatment
Catheter Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ischemic, Ventricular Tachycardia, Implantable Cardioverter Defibrillators, Antiarrhythmic Drug Therapy, Ablation, Electrophysiology
Eligibility Criteria
Inclusion Criteria:
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
- Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
- ICD implanted
- 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
- 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
- 18 years or older
- Able and willing to comply with all pre- and follow-up testing and requirements
- Signed Informed Consent Form
Exclusion Criteria:
- Age < 18 years
- Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram
- Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours)
- Contraindication to anticoagulation
- NYHA class IV
- Left ventricular assist devices (LVADs) or other circulatory assist devices
- 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.)
- Patients with active ischemia who are eligible for revascularization
- Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy)
- Other disease process likely to limit survival to less than 12 months
- Serum creatinine of ≥ 2.5mg/dl
- Thrombocytopenia or coagulopathy
- Prior ablation for Ventricular Tachycardia
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- Enrollment in an study evaluating an investigational device or drug
- Unable or unwilling to comply with protocol requirements
- Exclusively Polymorphic Ventricular Tachycardia
Sites / Locations
- University of California, Los Angeles
- California Pacific Medical Center
- San Francisco VA Medical Center
- University of California, San Francisco
- University of Colorado, Denver
- Florida Hospital
- Loyola University Chicago
- Central Baptist Hospital
- University of Maryland
- Johns Hopkins Hospital
- Brigham and Women's Hospital
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- University of Michigan
- Mayo Clinic
- Mount Sinai School of Medicine
- Columbia University- New York Presbyterian Hospital
- Cleveland Clinic Foundation
- Ohio State University
- University of Oklahoma
- University of Pennsylvania
- Texas Cardiac Arrhythmia Research Foundation
- St. Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment Group
Control Group
Arm Description
This group receives radiofrequency catheter ablation and drug treatment.
This group receives only drug treatment.
Outcomes
Primary Outcome Measures
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.
Cardiac-related Death
Subjects with cardiac-related death
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01557842
Brief Title
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
Acronym
ASPIRE
Official Title
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
March 19, 2014 (Actual)
Study Completion Date
March 19, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ischemic
Keywords
Ischemic, Ventricular Tachycardia, Implantable Cardioverter Defibrillators, Antiarrhythmic Drug Therapy, Ablation, Electrophysiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
This group receives radiofrequency catheter ablation and drug treatment.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
This group receives only drug treatment.
Intervention Type
Drug
Intervention Name(s)
Drug Treatment
Intervention Description
Class I and III antiarrhythmic drug treatment.
Intervention Type
Device
Intervention Name(s)
Catheter Ablation
Intervention Description
Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
Description
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
Title
Cardiac-related Death
Description
Subjects with cardiac-related death
Time Frame
2 years follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
ICD implanted
1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
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
18 years or older
Able and willing to comply with all pre- and follow-up testing and requirements
Signed Informed Consent Form
Exclusion Criteria:
Age < 18 years
Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram
Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours)
Contraindication to anticoagulation
NYHA class IV
Left ventricular assist devices (LVADs) or other circulatory assist devices
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.)
Patients with active ischemia who are eligible for revascularization
Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy)
Other disease process likely to limit survival to less than 12 months
Serum creatinine of ≥ 2.5mg/dl
Thrombocytopenia or coagulopathy
Prior ablation for Ventricular Tachycardia
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
Enrollment in an study evaluating an investigational device or drug
Unable or unwilling to comply with protocol requirements
Exclusively Polymorphic Ventricular Tachycardia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Callans, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis Marchlinski, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Wilber, MD
Organizational Affiliation
Loyola University
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02199
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University- New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
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