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

NCT ID: NCT01557842

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2014-03-19

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.

Conditions

Ventricular Tachycardia; Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

This group receives radiofrequency catheter ablation and drug treatment.

Group Type: ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type: DEVICE

Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.

Control Group

This group receives only drug treatment.

Group Type: EXPERIMENTAL

Drug Treatment

Intervention Type: DRUG

Class I and III antiarrhythmic drug treatment.

Interventions

Drug Treatment

Class I and III antiarrhythmic drug treatment.

Intervention Type: DRUG

Catheter Ablation

Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Callans, MD

Role: STUDY_CHAIR

University of Pennsylvania

Francis Marchlinski, MD

Role: STUDY_CHAIR

University of Pennsylvania

Andrea Natale, MD

Role: STUDY_CHAIR

Texas Cardiac Arrhythmia Research Foundation

Vivek Reddy, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

David Wilber, MD

Role: STUDY_CHAIR

Loyola University

Locations

University of California, Los Angeles

Los Angeles, California, United States

California Pacific Medical Center

San Francisco, California, United States

San Francisco VA Medical Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

Florida Hospital

Orlando, Florida, United States

Loyola University Chicago

Maywood, Illinois, United States

Central Baptist Hospital

Lexington, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Mount Sinai School of Medicine

New York, New York, United States

Columbia University- New York Presbyterian Hospital

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

ASPIRE

Identifier Type: -

Identifier Source: org_study_id