Therapy Cool Path Ablate VT

Not Applicable

Terminated

Conditions: Ischemic Ventricular Tachycardia

Interventions: Device: Therapy Cool Path Duo Cardiac Ablation System

Registration Number: NCT00925522

Lead Sponsor: Abbott Medical Devices

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 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 20

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%

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy Cool Path Duo Cardiac Ablation System	Therapy Cool Path Duo Cardiac Ablation System	All patients who are eligible receive cardiac ablation procedure for Ischemic Ventricular Tachycardia

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Loyola University Medical Center
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Maywood, Illinois, United States
Krannert Institute of Cardiology
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Indianapolis, Indiana, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States