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

NCT01557842 | Terminated Phase 4 Results

• 1 other identifier: ASPIRE
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 23

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

Keywords

Ischemic; Ventricular Tachycardia; Implantable Cardioverter Defibrillators; Antiarrhythmic Drug Therapy; Ablation; Electrophysiology

Outcome Measures

Primary Outcomes (2)

• 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.

  From one month to 2 years follow up

• Cardiac-related Death

  Subjects with cardiac-related death

  2 years follow up

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

This group receives radiofrequency catheter ablation and drug treatment.

Device: Catheter Ablation

Control Group

EXPERIMENTAL

This group receives only drug treatment.

Drug: Drug Treatment

Interventions

Drug Treatment DRUG

Class I and III antiarrhythmic drug treatment.

Control Group

Catheter Ablation DEVICE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• years or older
• Able and willing to comply with all pre- and follow-up testing and requirements
• Signed Informed Consent Form

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (23)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02199, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University- New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ischemia

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Please note that this study was terminated early and only 15 subjects were enrolled. As a result the reported results might be unreliable (unmonitored) and limited.

Results Point of Contact

• Title: Karen Cropper, Manager, Clinical Operations
• Organization: Biosense Webster, Inc.

Kcropper@its.jnj.com

(800) 729-9010

Study Officials

• 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

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• David Wilber, MD

  Loyola University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: June 1, 2012
• Primary Completion: March 19, 2014
• Study Completion: March 19, 2014
• Last Updated: June 8, 2017
• Results First Posted: January 1, 2015

Record last verified: 2017-05

Locations

US (23)