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Trial record 23 of 135 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT03388905
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Ilan Goldenberg, MD, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Tachycardia-induced Cardiomyopathy Device: Life Vest Wearable defibrilator Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy. A Prospective Study
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: Wearable Cardioverter Defibrillator group 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.




Primary Outcome Measures :
  1. Left ventricular recovery following WCD use. [ Time Frame: 3 months ]
    Left ventricular recovery following WCD use.


Secondary Outcome Measures :
  1. Recurrence of atrial tachyarrhythmias [ Time Frame: 12 months ]
    Recurrence of atrial tachyarrhythmias

  2. Recurrence of ventricular tachyarrhythmias [ Time Frame: 12 months ]
    Recurrence of ventricular tachyarrhythmias

  3. Appropriate shocks by WCD [ Time Frame: 3 months ]
    Occurrence of appropriate shocks as recorded by WCD (number of Shocks delivered during the follow up period)

  4. Inappropriate shocks by WCD [ Time Frame: 3 months ]
    Occurrence of Inappropriate shocks as recorded by WCD (number of Inappropriate Shocks delivered during the follow up period)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388905


Contacts
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Contact: Ilan Goldenberg, Prof 972-3-532848 Ilan.Goldenberg@sheba.health.gov.il
Contact: Nava Levine

Locations
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Israel
Sheba Medical Center
Ramat Gan, Israel, 5262179
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Prof. Ilan Goldenberg, MD, Professor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03388905     History of Changes
Other Study ID Numbers: TICMP
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Prof. Ilan Goldenberg, MD, Sheba Medical Center:
LifeVest wearable
cardioverter defibrillator
LVEF
Additional relevant MeSH terms:
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Cardiomyopathies
Tachycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes