Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators (ASPIRE)
This study is currently recruiting participants.
Verified April 2013 by Biosense Webster, Inc.
Sponsor:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01557842
First received: March 16, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventricular Tachycardia Ischemic |
Drug: Drug Treatment Device: Catheter Ablation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators |
Resource links provided by NLM:
Further study details as provided by Biosense Webster, Inc.:
Primary Outcome Measures:
- Appropriate ICD shocks (>2) for the treatment of VT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Slow VT below ICD detection threshold leading to hospitalization or necessitates an increase in the AAD regimen and/or repeat ablation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- VT storm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Hospitalization for VT-related causes/events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Cardiac-related death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Ablation of a Control, or reablation of a Treatment subject post hospital discharge [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first occurrence of appropriate device therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of appropriate ICD shocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Total VT burden (episodes) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time to first occurrence of hospitalization for cardiovascular causes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Occurrence of early onset (within seven (7) days of study ablation with the study catether) primary adverse events for the Catheter Ablation Group (Treatment) only [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Occurrence of primary adverse events which occur following randomization through end of study for both Treatment and Control Groups. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Occurrence of peri-procedural serious adverse events >7 days but ≤30 days from the date of ablation procedure (for subjects randomized to the Catheter Ablation Group (Treatment)) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
- 1 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
- 18 years or older
- Able and willing to comply with all pre- and follow-up testing and requirements
- Signed Informed Consent Form
Exclusion Criteria:
- 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
- Unable or unwilling to comply with protocol requirements
- Exclusively Polymorphic Ventricular Tachycardia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557842
Show 23 Study Locations
Contacts
| Contact: Karen Cropper | 909-839-8607 | |
| Contact: Stephanie Plaza | 909-839-8443 |
Show 23 Study LocationsSponsors and Collaborators
Biosense Webster, Inc.
Investigators
| 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 | Mount Sinai School of Medicine |
| Study Chair: | David Wilber, MD | Loyola University |
More Information
No publications provided
| Responsible Party: | Biosense Webster, Inc. |
| ClinicalTrials.gov Identifier: | NCT01557842 History of Changes |
| Other Study ID Numbers: | ASPIRE |
| Study First Received: | March 16, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biosense Webster, Inc.:
|
Ischemic Ventricular Tachycardia Implantable Cardioverter Defibrillators |
Antiarrhythmic Drug Therapy Ablation Electrophysiology |
Additional relevant MeSH terms:
|
Ischemia Tachycardia Tachycardia, Ventricular Pathologic Processes Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013