Clinical trial NCT01557842: Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
Official title: Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Ischemic
Keywords: Ischemic
Ventricular Tachycardia
Implantable Cardioverter Defibrillators
Antiarrhythmic Drug Therapy
Ablation
Electrophysiology
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
timeFrame: From one month to 2 years follow up
measure: Cardiac-related Death
timeFrame: 2 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University- New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: David Callans, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Francis Marchlinski, MD
role: STUDY_CHAIR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: STUDY_CHAIR
affiliation: Loyola University
name: David Wilber, MD
role: STUDY_CHAIR
References: