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Heart Failure Optimization Study (HF-Opt)

This study is currently recruiting participants.
Verified August 2017 by Zoll Medical Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03016754
First Posted: January 11, 2017
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Zoll Medical Corporation
  Purpose
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

Condition Intervention
Sudden Cardiac Death Sudden Cardiac Arrest Heart Failure Heart Failure Low Output Device: Wearable Cardioverter Defibrillator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Failure Optimization Study

Resource links provided by NLM:


Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • Do not require ICD implant [ Time Frame: 180 days ]
    Patient improved (EF >35%), SCD risk deemed to be negligible. These patients will end WCD use and not receive an ICD.

  • Continue WCD use [ Time Frame: 180 days ]
    Patient improved EF from start of WCD use (a positive change of at least 5 percentage points in EF), or has a borderline EF of 30-35%, but still has continued SCD risk (EF ≤ 35%). These patients are expected to continue to use the WCD for an additional 3 months.

  • Meet GDMT [ Time Frame: 180 days ]
    Patient not improved from start of WCD use (no change or worsening of EF), EF<30% and has continued high SCD risk. These patients will either continue the WCD for an additional 90 days if not on GDMT, or receive an ICD if already on GDMT.


Secondary Outcome Measures:
  • Incidence of other arrhythmias [ Time Frame: 180 days ]
    Observe the incidence of other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device.

  • Determine the number of ICD treatment shocks [ Time Frame: 180 days ]
    Collect ICD treatment data for those who receive an ICD, and evaluate for appropriateness as assessed by ECG recordings.

  • Efficacy in ventricular arrhythmias [ Time Frame: 180 days ]
    Observe the effectiveness of the wearable defibrillator worn by this population in treating ventricular arrhythmias. Clinical outcomes data from any defibrillation or cardiac event will be collected, including device data on appropriate arrhythmia detection and shock delivery.

  • Mortality following hospital discharge [ Time Frame: 360 days ]
    Evaluate the effect of wearable defibrillators on 90,180, 270, and 360-day mortality following discharge in HF patients. Assessment of survival will be made at these time points for those entered into the study. A mortality review will be conducted to group all deaths as cardiac or non-cardiac, and sudden or non-sudden.

  • Cost of healthcare utilization [ Time Frame: 360 days ]
    Assess cost of healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study.


Other Outcome Measures:
  • Complications from extended use [ Time Frame: 360 days ]
    The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study timeframe.


Estimated Enrollment: 750
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Wearable Cardioverter Defibrillator
    LifeVest Wearable Cardioverter Defibrillator
    Other Name: LifeVest
Detailed Description:
This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge, with the option for longer use under physician discretion. Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In-Hospital
Criteria

Inclusion Criteria:

Part 1

  • Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD for no more than 30 days.
  • Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times).

Part 2

  • Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days.
  • Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not need to be low to be included in the study.

Exclusion Criteria:

  • Patients under 18 years old.
  • Patients who have an active unipolar pacemaker.
  • Patients with a physical or mental condition that could impair their ability to properly interact with the device.
  • Patients currently participating in another clinical study.
  • Patients with any skin condition that would prevent wearing the device.
  • Patients with an advanced directive prohibiting resuscitation.
  • Patients who are indicated for cardiac resynchronization therapy or have a QRS duration of ≥135 ms.
  • Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).
  Contacts and Locations
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): NCT03016754


Contacts
Contact: Rachel Jackson 412-968-3333 ext 14118 rjackson@zoll.com
Contact: Mike Osz 412-721-6444 mosz@zoll.com

Locations
United States, California
Study Site Recruiting
Downey, California, United States, 90241
Contact: Multani         
Study Site Recruiting
West Hills, California, United States, 91307
Contact: Rafii         
United States, Florida
Study Site Recruiting
Ocala, Florida, United States, 34471
Contact: Gummadi         
Study Site Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Sanchez         
United States, Georgia
Study Site Recruiting
Rome, Georgia, United States, 30165
Contact: Garg         
United States, Illinois
Study Site Recruiting
Aurora, Illinois, United States, 60506
Contact: Muneer         
Study Site Recruiting
Hazel Crest, Illinois, United States, 60429
Contact: Chandra         
Study Site Recruiting
Peoria, Illinois, United States, 61602
Contact: Adler         
United States, Indiana
Study Site Recruiting
South Bend, Indiana, United States, 26554
Contact: Kobayashi         
United States, New Jersey
Study Site Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Mohapatra         
United States, Ohio
Study Site Recruiting
Barberton, Ohio, United States, 44203
Contact: Haque         
United States, Pennsylvania
Study Site Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Kaluski         
United States, South Carolina
Study Site Recruiting
Lancaster, South Carolina, United States, 29720
Contact: Shah         
United States, Texas
Study Site Recruiting
Beaumont, Texas, United States, 77702
Contact: Sotolongo         
Study Site Recruiting
New Braunfels, Texas, United States, 78130
Contact: Rubalcava         
Germany
Study Site Recruiting
Hannöver, Germany
Contact: Veltmann         
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Mike Osz Director, Clinical Operations
  More Information

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03016754     History of Changes
Other Study ID Numbers: 90D0109
First Submitted: January 4, 2017
First Posted: January 11, 2017
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zoll Medical Corporation:
sudden cardiac death
SCD
sudden cardiac arrest
SCA
heart failure
HF

Additional relevant MeSH terms:
Heart Failure
Heart Arrest
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden