Tachycardia-induced Cardiomyopathy Clinical Trial
Official title:
Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy. A Prospective Study
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05467163 -
Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation
|
N/A |