Status:
UNKNOWN
Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy
Lead Sponsor:
Sheba Medical Center
Conditions:
Tachycardia-induced Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 un...
Detailed Description
TachycardiaInduced Cardiomyopathy (TICMP) refers to impairment in left ventricular function secondary to chronic tachycardia, which is partially or completely reversible once the tachyarrhythmia is co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03388905
Start Date
January 15 2018
End Date
December 31 2019
Last Update
January 3 2018
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 5262179