Status:
TERMINATED
Therapy Cool Path Ablate VT
Lead Sponsor:
Abbott Medical Devices
Conditions:
Ischemic Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
Ventricular Tachycardia (VT) is a common complication of ischemic heart disease that is often life threatening. Ventricular tachycardia is defined as three or more beats of ventricular origin in succe...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00925522
Start Date
June 1 2009
End Date
July 1 2011
Last Update
April 17 2019
Active Locations (5)
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1
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
4
Kansas University Medical Center
Kansas City, Kansas, United States, 66160