Heart Failure Optimization Study (HF-Opt)
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|ClinicalTrials.gov Identifier: NCT03016754|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : June 9, 2022
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|Condition or disease||Intervention/treatment|
|Sudden Cardiac Death Sudden Cardiac Arrest Heart Failure Heart Failure Low Output||Device: Wearable Cardioverter Defibrillator|
|Study Type :||Observational|
|Actual Enrollment :||622 participants|
|Official Title:||Heart Failure Optimization Study|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||June 1, 2022|
|Actual Study Completion Date :||June 1, 2022|
- Device: Wearable Cardioverter Defibrillator
LifeVest Wearable Cardioverter DefibrillatorOther Name: LifeVest
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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).
- 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.
- 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).
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
|Study Director:||Mike Osz||Director, Clinical Operations|
|Responsible Party:||Zoll Medical Corporation|
|Other Study ID Numbers:||
|First Posted:||January 11, 2017 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
sudden cardiac death
sudden cardiac arrest
Death, Sudden, Cardiac