Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT) (Ablate-VT)
|ClinicalTrials.gov Identifier: NCT00925522|
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : May 27, 2016
Last Update Posted : March 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Ventricular Tachycardia||Device: Therapy Cool Path Duo Cardiac Ablation System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT)|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||July 2011|
U.S. FDA Resources
Experimental: Therapy Cool Path Duo Cardiac Ablation System
All patients who are eligible receive cardiac ablation procedure for Ischemic Ventricular Tachycardia
Device: Therapy Cool Path Duo Cardiac Ablation System
Cardiac Ablation Procedure for Ischemic VT using a flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.
1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.
- Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure. [ Time Frame: 7 days ]
- Acute Success is Achieved When All Clinically Relevant VT Substrates (Spontaneous and Induced VT Episodes) Are Terminated and no Longer Inducible Upon Hospital Discharge (i.e., Last Study Ablation Procedure Prior to Hospital Discharge). [ Time Frame: Hospital Discharge ]Summarized as number of subjects with clinically relevant VT substrates (spontaneous and induced VT episodes) that are terminated and no longer inducible upon hospital discharge - from the last study ablation procedure prior to hospital discharge.
- Chronic Success is Defined at 6 Months Following the RF Ablation Procedure as no Recurrence of Clinically Relevant VT(s) That Were Targeted at Ablation. [ Time Frame: 6 months ]Summarized as the number of subjects with recurrence of clinically relevant VT(s) that were targeted at ablation at 6 months following the RF ablation procedure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925522
|United States, Alabama|
|University Hospital - Univ. of Alabama at Birmingham (UAB)|
|Birmingham, Alabama, United States, 35233|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Indiana|
|Krannert Institute of Cardiology|
|Indianapolis, Indiana, United States, 46202|
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||G. Neal Kay, M.D.||University of Alabama at Birmingham|