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Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy

NCT03388905 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-03

No results posted yet for this study

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 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.

Conditions

  • Tachycardia-induced Cardiomyopathy

Interventions

DEVICE

Life Vest Wearable defibrilator

The LifeVest is a cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). It monitors the patient's heart continuously and, if the patient goes into a life-threatening arrhythmia, can deliver a shock treatment to restore the patient's heart to normal rhythm.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388905 on ClinicalTrials.gov