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

Ventricular Tachycardia Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01557842
• Other study ID #: ASPIRE
• Status: Terminated
• Phase: Phase 4
• First received: March 16, 2012
• Last updated: December 19, 2014
• Start date: June 2012
• Est. completion date: September 2017

Study information

• Verified date: December 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Drug:
• Drug Treatment
Class I and III antiarrhythmic drug treatment.

Device:
• Catheter Ablation
Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado, Denver	Aurora	Colorado
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Central Baptist Hospital	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	Loyola University Chicago	Maywood	Illinois
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Columbia University- New York Presbyterian Hospital	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
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

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Cardiac-related Death	Subjects with cardiac-related death	2 years follow up	Yes