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

Phase 4

Terminated

• Conditions: Ventricular Tachycardia; Ischemic
• Interventions: Device: Catheter Ablation; Drug: Drug Treatment

• Registration Number: NCT01557842
• Lead Sponsor: Biosense Webster, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Study Start: 2012-06-01
• Primary Completion: 2014-03-19
• Study Completion: 2014-03-19
• Results First Submitted: 2014-12-19
• Results First Submitted QC: 2014-12-19
• Results First Posted: 2015-01-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-13
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Catheter Ablation	This group receives radiofrequency catheter ablation and drug treatment.
Control Group	Drug Treatment	This group receives only drug treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events	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	2 years follow up	Subjects with cardiac-related death

Trial Locations

Locations (23)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Columbia University- New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Loyola University Chicago; 🇺🇸 Maywood, Illinois, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Central Baptist Hospital; 🇺🇸 Lexington, Kentucky, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States