Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy

December 25, 2017 updated by: Prof. Ilan Goldenberg, MD, Sheba Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Nava Levine

Study Locations

  • Israel
      • Ramat Gan, Israel, 5262179
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Left ventricular recovery following WCD use.
Time Frame: 3 months
Left ventricular recovery following WCD use.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence of atrial tachyarrhythmias
Time Frame: 12 months
Recurrence of atrial tachyarrhythmias
12 months
Recurrence of ventricular tachyarrhythmias
Time Frame: 12 months
Recurrence of ventricular tachyarrhythmias
12 months
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)
3 months
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TICMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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