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Heart Failure Optimization Study (HF-Opt)

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.
 
ClinicalTrials.gov Identifier: NCT03016754
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Tracking Information
First Submitted Date January 4, 2017
First Posted Date January 11, 2017
Last Update Posted Date September 30, 2020
Actual Study Start Date March 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2017)
  • 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.
Original Primary Outcome Measures
 (submitted: January 6, 2017)
  • 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: 270 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: 270 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.
Change History
Current Secondary Outcome Measures
 (submitted: January 6, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 6, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Heart Failure Optimization Study
Official Title Heart Failure Optimization Study
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population In-Hospital
Condition
  • Sudden Cardiac Death
  • Sudden Cardiac Arrest
  • Heart Failure
  • Heart Failure Low Output
Intervention Device: Wearable Cardioverter Defibrillator
LifeVest Wearable Cardioverter Defibrillator
Other Name: LifeVest
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 6, 2017)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rachel Jackson 412-968-3333 ext 14118 rjackson@zoll.com
Contact: Mike Osz 412-721-6444 mosz@zoll.com
Listed Location Countries Austria,   France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03016754
Other Study ID Numbers 90D0109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zoll Medical Corporation
Study Sponsor Zoll Medical Corporation
Collaborators Not Provided
Investigators
Study Director: Mike Osz Director, Clinical Operations
PRS Account Zoll Medical Corporation
Verification Date September 2020