Therapy Cool Path Ablate VT
Therapy Cool Path Ablate VT
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.
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 succession at a rate greater than 100 beats per minute. There are no normal QRS
 complexes associated with VT, and the rhythm is usually regular. Patients with VT experience
 unpleasant heart palpitations, dyspnea, and syncope, all of which decrease their overall
 quality of life. They also suffer the consequences of impaired hemodynamics, loss of cardiac
 efficiency, and are at an increased risk of sudden cardiac death (SCD), which accounts for
 approximately half of all deaths from patients with cardiovascular disease.

 Historically, antiarrhythmic medications served as the first line therapy for the treatment
 of VT, in spite of low efficacy and high recurrence rates. But in recent years, internal
 cardioverter defibrillators (ICDs) have become the treatment of choice. Although, ICDs are
 effective in terminating most arrhythmias, rarely does so without some episodes requiring
 poorly tolerated shock therapy. Ablative therapy offers an important option for frequent
 control with the potential for long-term VT elimination. Radiofrequency catheter ablation
 offers the ability to provide immediate control of recurrent VT. Since the early 2000's,
 strategies, tools, and techniques have been improving to identify key ablation sites and to
 deliver effective lesions.

 Radiofrequency ablation is successful in treating some but not all arrhythmias. With non
 irrigated technology it has been difficult to ablate ischemic VT. This may be due to an
 inadequate lesion size. Irrigated electrodes were developed to create larger lesions. Open
 irrigation at the catheter tip not only produces larger lesions, but also helps reduce the
 risk of coagulum (clots) and charring due to high temperatures.
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%