Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators (ASPIRE)
|ClinicalTrials.gov Identifier: NCT01557842|
Recruitment Status : Terminated
First Posted : March 20, 2012
Results First Posted : January 1, 2015
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia Ischemic||Drug: Drug Treatment Device: Catheter Ablation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators|
|Actual Study Start Date :||June 1, 2012|
|Actual Primary Completion Date :||March 19, 2014|
|Actual Study Completion Date :||March 19, 2014|
U.S. FDA Resources
Active Comparator: Treatment Group
This group receives radiofrequency catheter ablation and drug treatment.
Device: Catheter Ablation
Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
Experimental: Control Group
This group receives only drug treatment.
Drug: Drug Treatment
Class I and III antiarrhythmic drug treatment.
- Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events [ Time Frame: 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 [ Time Frame: 2 years follow up ]Subjects with cardiac-related death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557842
Show 23 Study Locations
|Study Chair:||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|