Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy

NCT03388905 | Unknown FDA Device

• 1 other identifier: TICMP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Keywords

LifeVest wearable; cardioverter defibrillator; LVEF

Outcome Measures

Primary Outcomes (1)

• Left ventricular recovery following WCD use.

  Left ventricular recovery following WCD use.

  3 months

Secondary Outcomes (4)

• Recurrence of atrial tachyarrhythmias

  12 months

• Recurrence of ventricular tachyarrhythmias

  12 months

• Appropriate shocks by WCD

  3 months

• Inappropriate shocks by WCD

  3 months

Study Arms (1)

Wearable Cardioverter Defibrillator group

EXPERIMENTAL

Device: Life Vest Wearable defibrilator

Interventions

Life Vest Wearable defibrilator DEVICE

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.

Wearable Cardioverter Defibrillator group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262179, Israel

Location

Central Study Contacts

Ilan Goldenberg, Prof

CONTACT

972-3-532848; Ilan.Goldenberg@sheba.health.gov.il

Nava Levine

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: January 3, 2018
• Study Start: January 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)