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The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
NAVISTAR® THERMOCOOL® Catheter
University of Alabama, Birmingham
Biosense Webster, Inc.
Published on BioPortfolio: 2014-07-23T21:34:27-0400
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® ir...
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. It is cur...
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atri...
To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug thera...
The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ...
Catheter ablation of ventricular tachycardia (VT) is associated with the risk of cerebral embolism. The origin of periprocedural brain embolism in the setting of VT ablation is often unknown and strat...
Current ventricular tachycardia (VT) management in patients with ischemic cardiomyopathy (ICM) includes optimal medical therapy, ICDs device therapy, and antiarrhythmic medications. Data about outcome...
The comparative efficacy of antiarrhythmic drug therapy (AAD) versus ventricular tachycardia (VT) ablation in arrhythmogenic right ventricular cardiomyopathy (ARVC) is unknown.
Prognostic Significance of Non-Sustained Ventricular Tachycardia Depends on Its Rate and DurationNon-sustained ventricular tachycardia episodes predict future hospitalization in ICD recipients with heart failure.
The PAINESD risk score predicts the risk of periprocedural acute hemodynamic decompensation (AHD) and post-procedural mortality in patients (pts) undergoing catheter ablation (CA) of scar-related vent...
Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes.
An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).
A malignant form of polymorphic ventricular tachycardia that is characterized by HEART RATE between 200 and 250 beats per minute, and QRS complexes with changing amplitude and twisting of the points. The term also describes the syndrome of tachycardia with prolonged ventricular repolarization, long QT intervals exceeding 500 milliseconds or BRADYCARDIA. Torsades de pointes may be self-limited or may progress to VENTRICULAR FIBRILLATION.
Cardiac electrical stimulators that apply brief high-voltage electroshocks to the HEART. These stimulators are used to restore normal rhythm and contractile function in hearts of patients who are experiencing VENTRICULAR FIBRILLATION or ventricular tachycardia (TACHYCARDIA, VENTRICULAR) that is not accompanied by a palpable PULSE. Some defibrillators may also be used to correct certain noncritical dysrhythmias (called synchronized defibrillation or CARDIOVERSION), using relatively low-level discharges synchronized to the patient's ECG waveform. (UMDNS, 2003)
A potentially lethal cardiac arrhythmia characterized by an extremely rapid, hemodynamically unstable ventricular tachycardia (150-300 beats/min) with a large oscillating sine-wave appearance. If untreated, ventricular flutter typically progresses to VENTRICULAR FIBRILLATION.