Ischemic Ventricular Tachycardia Clinical Trial
Official title:
Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (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.
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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 |
NCT00558857 -
Dynamic Substrate Mapping (DSM) for Ischemic VT
|
Phase 1 |