Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy
Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy
The purpose of this current study is to prospectively enroll consecutive patients
 hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which
 the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy.
 Patients completing their established in-hospital treatment plan with rate or rhythm control,
 will be discharged with a WCD following informed consent and detailed counseling by
 healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the
 need for ICD implantation.
TachycardiaInduced Cardiomyopathy (TICMP) refers to impairment in left ventricular function
 secondary to chronic tachycardia, which is partially or completely reversible once the
 tachyarrhythmia is controlled. Tachycardia-induced cardiomyopathy has been shown to occur
 both in experimental models and in patients with incessant tachyarrhythmia (mostly commonly
 uncontrolled atrial fibrillation). Control of ventricular rate or rhythm by means of
 cardio-version, negative chronotropic agents, anti-arrhythmic medication and surgical or
 catheter-based ablation, resulted in significant improvement of systolic function. However,
 until a possible improvement in left ventricular ejection fraction (LVEF), patients with
 TICMP with severely depressed systolic function may remain at a high-risk for
 life-threatening ventricular arrhythmias and sudden cardiac death. While implantable
 cardioverter defibrillators (ICD) are indicated in patients who fail to improve their left
 ventricular ejection fraction (LVEF), currently there is no protection from sudden cardiac
 death (SCD) in patients with TICMP during the high-risk time period from hospital discharge
 until reassessment of cardiac function and the need for ICD implantation. In this population,
 the Life Vest wearable cardioverter defibrillator (WCD) may be an appropriate treatment
 option, providing protection from SCD through timely termination of life-threatening
 ventricular arrhythmias until stabilization of LVEF. In addition, the monitoring capabilities
 of the WCD may facilitate remote assessment heart rate control with appropriate titration of
 medical therapy and evaluation of recurrence of tachyarrhythmias following discharge from
 hospitalization. Accordingly, the proposed study is the first to prospectively evaluate the
 benefit of the WCD as an early management strategy in patients with TICMP.

 There is no available clinical research data to date on the study device used in TICMP.

 This proposed trial is a multicenter single armed prospective study. Thirty patients with
 newly diagnosed severe LV dysfunction due to uncontrolled tachyarrhythmia will be enrolled
 following their completion of established in-hospital treatment plan with rate or rhythm
 control.

 Enrolled patients will be discharged with a WCD for a time-period of 3 months. All patients
 will provide signed informed consent, and detailed counseling by healthcare personnel for a
 time-period of up to 3 months until reassessment of LVEF and the need for ICD implantation.

 The enrollment duration is expected to last 12 months and follow up of additional 12 months
 from patient inclusion will be performed. An estimation recruitment rate of 1-2 patients per
 month per center is reasonable based on our preliminary data (see section 6.1). Therefore, it
 is likely to end up patient's recruitment 10 months following the enrollment phase
 initiation.

 During follow up, patients will be contacted at (1) end of WCD use (2) 3 month and (3) 12
 months post enrollment.

 Total expected duration of study termination is 24 months from the time first patient was
 enrolled.
Inclusion Criteria:

 -  Patients with newly diagnosed left ventricular dysfunction (LVEF ≤ 35% following
 cardioversion or rate stabilization) with either of the following:

 -  Newly diagnosed atrial fibrillation

 -  High burden of premature ventricular contractions (PVCs) (15% of total beats on
 24-hour ambulatory Holter recording with a rapid ventricular response > 100 beats
 per minute prior to initiation of medical therapy) and no other likely heart
 failure (HF) etiology

 -  Appropriate management during hospitalization with cardioversion and rhythm control
 (preferable) or rate control (if cardioversion is contraindicated due to a left atrial
 thrombus or is not successful)

 Exclusion Criteria:

 -  HF likely due to an etiology other than tachyarrhythmia (ischemic etiology,
 myocarditis, hypertrophic or dilated cardiomyopathy, etc.)

 -  Unstable clinical condition, life threatening arrhythmia or an established indication
 for ICD/CRT-D implantation during the index hospitalization

 -  Patients with ICD/CRT-D or established (> 3 months) heart failure

 -  Cognitive impairment or unable to utilize WCD appropriately

 -  Patient has a chest circumference at the level of the xiphoid process either less than
 26 inches or greater than 56 inches