Ischemic Ventricular Tachycardia Clinical Trial
— Ablate-VTOfficial title:
Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT)
NCT number | NCT00925522 |
Other study ID # | G080076 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | July 2011 |
Verified date | April 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can eliminate ischemic VT and that its use does not result in an unacceptable risk of serious adverse events.
Status | Terminated |
Enrollment | 20 |
Est. completion date | July 2011 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is 18 years of age or older - Patient has an ICD (Implantable Cardiac Defibrillator) or will be implanted with one prior to discharge of ablation procedure - Patient has had at least 2 documented spontaneous episode of sustained ischemic VT (Ventricular Tachycardia) within the previous 6 months - Patient is resistant, intolerant or refractory to at least one Class I or III AAD (Anti-Arrhythmic Drug) - Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board Exclusion Criteria: - Non-ischemic VT - History of stroke or transient ischemic attack within 6 months prior to enrollment - MI or previous cardiac surgery within 2 months prior to enrollment - Patient is pregnant or nursing - Patient has chronic NYHA (New York Heart Association) class IV heart failure - Limited life expectancy of 6 months or less - Patient is currently participating in another investigational drug or device study - Patient is unable or unwilling to cooperate with the study procedures - Known presence of intracardiac thrombi - Severe aortic stenosis or flailed mitral valve - Major contraindication to anticoagulation therapy or coagulation disorder - Left Ventricular Ejection Fraction <10% |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Krannert Institute of Cardiology | Indianapolis | Indiana |
United States | Kansas University Medical Center | Kansas City | Kansas |
United States | Loyola University Medical Center | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure. | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01032317 -
Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
|
Phase 1/Phase 2 | |
Terminated |
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Dynamic Substrate Mapping (DSM) for Ischemic VT
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Phase 1 |