Heart Failure, Heart Failure Low Output, Sudden Cardiac Arrest, Sudden Cardiac Death
Conditions
Keywords
sudden cardiac death (SCD), sudden cardiac arrest (SCA), heart failure (HF), heart failure with reduced ejection fraction (HFrEF), guideline directed medical therapy (GDMT), guideline recommended medical therapy (GRMT), wearable cardioverter defibrillator (WCD)
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.
Interventions
LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.
Sponsors
Zoll Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 (Registry phase) * 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). Phase 2 (Study phase) * Patients who completed Phase 1 and used a WCD for 90 ± 14 days.
Exclusion criteria
(both phases): * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | 180 days | Descriptive statistics will be used to assess the percentage of study subjects reaching target doses of GDMT at 90 and 180 days. All eligible study subjects with LVEF data at all three timepoints were used for this analysis. |
| Percentage of Patients With LVEF Recovery at Day 90 and 180 | 180 days | The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use | 360 days | Observe the occurrence of all sustained VT/VF arrhythmias during WCD use by event. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
| Percentage of All Patients Having Other Arrhythmias | 180 days | Observe the percentage of patients having other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
| Efficacy in Treating Ventricular Arrhythmias | 180 days | Observe the effectiveness of the wearable cardioverter defibrillator worn by this population in treating ventricular arrhythmias. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
| Mortality Analysis | 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months) | Evaluate the effect of wearable defibrillators on 180, 270, and 360-day mortality following discharge in HF patients. Cumulative assessment of survival will be made at these time points for those entered into the study (e.g. up to 180, 270, 360 days, or \>360 days (up to 14 months)). A mortality review will be conducted by independent adjudicators to group all deaths as cardiac or non-cardiac, and sudden or non-sudden. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. Data collected on deaths after the prespecified final timepoint (n=3) will be labeled \>360 days (up to 14 months). 1 subject completed the study immediately prior to the reported death, hence the different number from the participant flow. |
| Healthcare utilization_type | 360 days | Healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
| Healthcare utilization_length of Use | 360 days | Length of stay for any hospitalization, observation, skilled nursing facility stays. All eligible study subjects reporting one of these stays were used for this analysis, and grouped by type of stay. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
| All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use | 360 days | Observe the percentage of patients having sustained VT/VF arrhythmias during WCD use. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications From Extended Use | 360 days | The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study phase timeframe. All eligible study subjects were used for this safety analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. |
Countries
Austria, France, Germany, United States
Participant flow
Pre-assignment details
Patients were initially screened from the prescribed wearable cardioverter defibrillator (WCD) patients and enrolled into a pre-study registry (n=1300). At 90 +/- 14 days of WCD use, patients were screened from the site's pre-study registry participants. Subjects determined to be ineligible for the study or those exiting the registry before study phase were excluded (n=698). The study phase started at day 90.
Participants by arm
| Arm | Count |
|---|---|
| Early Recovery Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines. | 279 |
| Improvement Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days. | 214 |
| Non-improvement Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days. | 90 |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) Study subjects missing a day 90 LVEF value and were unable to be assigned to a group. | 19 |
| Total | 602 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 5 | 4 | 5 | 1 |
| Overall Study | Lost to Follow-up | 23 | 17 | 4 | 2 |
| Overall Study | Other/Unknown | 2 | 4 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 6 | 2 | 2 |
Baseline characteristics
| Characteristic | Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | Early Recovery | Improvement | Non-improvement | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 13 |
| Body Mass Index (BMI) | 28.7 kg/m^2 STANDARD_DEVIATION 6.2 | 30.0 kg/m^2 STANDARD_DEVIATION 7.4 | 29.0 kg/m^2 STANDARD_DEVIATION 6.4 | 29.8 kg/m^2 STANDARD_DEVIATION 7.2 | 29.6 kg/m^2 STANDARD_DEVIATION 7 |
| History of arrhythmia in past year Atrial fibrillation | 2 Participants | 68 Participants | 31 Participants | 12 Participants | 113 Participants |
| History of arrhythmia in past year Atrial Flutter | 2 Participants | 14 Participants | 8 Participants | 0 Participants | 24 Participants |
| History of arrhythmia in past year First-degree AV block | 1 Participants | 2 Participants | 4 Participants | 0 Participants | 7 Participants |
| History of arrhythmia in past year Paced rhythm | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| History of arrhythmia in past year Sinus bradycardia | 0 Participants | 5 Participants | 3 Participants | 2 Participants | 10 Participants |
| History of arrhythmia in past year Sinus tachycardia | 0 Participants | 35 Participants | 36 Participants | 14 Participants | 85 Participants |
| History of arrhythmia in past year Supraventricular tachycardia | 0 Participants | 6 Participants | 5 Participants | 2 Participants | 13 Participants |
| History of arrhythmia in past year Third degree AV block | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| History of arrhythmia in past year Type II Second-degree AV block | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| History of arrhythmia in past year Type I Second-degree AV block | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| History of arrhythmia in past year Ventricular fibrillation | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| History of arrhythmia in past year Ventricular tachycardia | 2 Participants | 8 Participants | 2 Participants | 1 Participants | 13 Participants |
| History of arrhythmia in past year Ventricular tachycardia (non-sustained | 1 Participants | 9 Participants | 11 Participants | 8 Participants | 29 Participants |
| History of chronic kidney disease | 2 Participants | 29 Participants | 24 Participants | 11 Participants | 66 Participants |
| History of chronic obstructive pulmonary disease (COPD) | 0 Participants | 37 Participants | 17 Participants | 17 Participants | 71 Participants |
| History of coronary artery bypass graft surgery | 3 Participants | 25 Participants | 15 Participants | 9 Participants | 52 Participants |
| History of diabetes | 7 Participants | 69 Participants | 61 Participants | 27 Participants | 164 Participants |
| History of hypertension (HTN) | 14 Participants | 196 Participants | 122 Participants | 54 Participants | 386 Participants |
| History of myocardial infarction | 5 Participants | 66 Participants | 30 Participants | 28 Participants | 129 Participants |
| History of percutaneous coronary intervention | 6 Participants | 71 Participants | 34 Participants | 23 Participants | 134 Participants |
| History of sudden cardiac arrest | 1 Participants | 7 Participants | 3 Participants | 7 Participants | 18 Participants |
| History of transient ischemic attack/Cerebrovascular accident | 1 Participants | 18 Participants | 18 Participants | 5 Participants | 42 Participants |
| Initial heart rate | 74 Beats per minute STANDARD_DEVIATION 23 | 80 Beats per minute STANDARD_DEVIATION 17 | 84 Beats per minute STANDARD_DEVIATION 18 | 85 Beats per minute STANDARD_DEVIATION 16 | 82 Beats per minute STANDARD_DEVIATION 18 |
| Initial respiration rate | 16 Breaths per minute STANDARD_DEVIATION 2 | 17 Breaths per minute STANDARD_DEVIATION 3 | 17 Breaths per minute STANDARD_DEVIATION 3 | 17 Breaths per minute STANDARD_DEVIATION 3 | 17 Breaths per minute STANDARD_DEVIATION 3 |
| Ischemic cardiomyopathy | 8 Participants | 113 Participants | 70 Participants | 39 Participants | 230 Participants |
| Mixed cardiomyopathy | 1 Participants | 10 Participants | 9 Participants | 4 Participants | 24 Participants |
| New York Heart Association (NYHA) functional class at index hospitalization Class I | 1 Participants | 7 Participants | 6 Participants | 0 Participants | 14 Participants |
| New York Heart Association (NYHA) functional class at index hospitalization Class II | 3 Participants | 56 Participants | 40 Participants | 16 Participants | 115 Participants |
| New York Heart Association (NYHA) functional class at index hospitalization Class III | 6 Participants | 100 Participants | 77 Participants | 41 Participants | 224 Participants |
| New York Heart Association (NYHA) functional class at index hospitalization Class IV | 2 Participants | 31 Participants | 26 Participants | 7 Participants | 66 Participants |
| New York Heart Association (NYHA) functional class at index hospitalization Not documented | 7 Participants | 85 Participants | 65 Participants | 26 Participants | 183 Participants |
| New York Heart Association (NYHA) functional class at registry start Class I | 3 Participants | 17 Participants | 11 Participants | 3 Participants | 34 Participants |
| New York Heart Association (NYHA) functional class at registry start Class II | 3 Participants | 85 Participants | 70 Participants | 26 Participants | 184 Participants |
| New York Heart Association (NYHA) functional class at registry start Class III | 5 Participants | 68 Participants | 37 Participants | 27 Participants | 137 Participants |
| New York Heart Association (NYHA) functional class at registry start Class IV | 0 Participants | 5 Participants | 3 Participants | 1 Participants | 9 Participants |
| New York Heart Association (NYHA) functional class at registry start Not documented | 8 Participants | 104 Participants | 93 Participants | 33 Participants | 238 Participants |
| Non-ischemic cardiomyopathy | 10 Participants | 156 Participants | 135 Participants | 47 Participants | 348 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaskan native | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 2 Participants | 31 Participants | 27 Participants | 15 Participants | 75 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 15 Participants | 231 Participants | 173 Participants | 65 Participants | 484 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latin | 0 Participants | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiple races selected | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity No response | 1 Participants | 7 Participants | 8 Participants | 3 Participants | 19 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Austria | 4 participants | 10 participants | 1 participants | 1 participants | 16 participants |
| Region of Enrollment France | 4 participants | 3 participants | 6 participants | 2 participants | 15 participants |
| Region of Enrollment Germany | 3 participants | 115 participants | 92 participants | 30 participants | 240 participants |
| Region of Enrollment United States | 8 participants | 151 participants | 115 participants | 57 participants | 331 participants |
| Sex: Female, Male Female | 2 Participants | 88 Participants | 49 Participants | 25 Participants | 164 Participants |
| Sex: Female, Male Male | 17 Participants | 191 Participants | 165 Participants | 65 Participants | 438 Participants |
| Systolic blood pressure | 124 mmHg STANDARD_DEVIATION 20 | 124 mmHg STANDARD_DEVIATION 22 | 116 mmHg STANDARD_DEVIATION 19 | 118 mmHg STANDARD_DEVIATION 15 | 120 mmHg STANDARD_DEVIATION 20 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 279 | 4 / 214 | 6 / 90 | 1 / 19 |
| other Total, other adverse events | 8 / 279 | 14 / 214 | 3 / 90 | 0 / 19 |
| serious Total, serious adverse events | 0 / 279 | 1 / 214 | 0 / 90 | 0 / 19 |
Outcome results
Primary
Percentage of Patients With LVEF Recovery at Day 90 and 180
The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used.
Time frame: 180 days
Population: Subjects with all three LVEF measurements (baseline, day 90, day 180) were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Early Recovery | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 90 LVEF | Day 90 LVEF <=35% | 0 Participants |
| Early Recovery | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 180 LVEF | Day 90 LVEF >35% | 208 Participants |
| Early Recovery | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 90 LVEF | Day 90 LVEF >35% | 222 Participants |
| Early Recovery | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 180 LVEF | Day 90 LVEF <=35% | 14 Participants |
| Improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 90 LVEF | Day 90 LVEF <=35% | 186 Participants |
| Improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 90 LVEF | Day 90 LVEF >35% | 0 Participants |
| Improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 180 LVEF | Day 90 LVEF >35% | 97 Participants |
| Improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 180 LVEF | Day 90 LVEF <=35% | 89 Participants |
| Non-improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 180 LVEF | Day 90 LVEF >35% | 25 Participants |
| Non-improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 90 LVEF | Day 90 LVEF >35% | 0 Participants |
| Non-improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 90 LVEF | Day 90 LVEF <=35% | 79 Participants |
| Non-improvement | Percentage of Patients With LVEF Recovery at Day 90 and 180 | Day 180 LVEF | Day 90 LVEF <=35% | 54 Participants |
Primary
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Descriptive statistics will be used to assess the percentage of study subjects reaching target doses of GDMT at 90 and 180 days. All eligible study subjects with LVEF data at all three timepoints were used for this analysis.
Time frame: 180 days
Population: Subjects with all three LVEF measurements (baseline, day 90, day 180) were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Target dose not reached | 136 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Target dose not reached | 164 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Dose not available | 1 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Target dose reached | 86 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Target dose reached | 57 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Dose not available | 0 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Target dose reached | 114 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Target dose not reached | 108 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Dose not available | 0 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Target dose reached | 56 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Target dose not reached | 166 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Dose not available | 0 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Target dose reached | 92 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Target dose not reached | 130 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Dose not available | 0 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Target dose reached | 103 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Target dose not reached | 119 Participants |
| Early Recovery | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Dose not available | 0 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Dose not available | 0 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Target dose reached | 36 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Target dose reached | 47 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Target dose reached | 84 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Target dose not reached | 149 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Dose not available | 1 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Target dose reached | 84 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Dose not available | 1 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Target dose not reached | 139 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Target dose not reached | 102 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Target dose reached | 59 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Dose not available | 0 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Target dose not reached | 101 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Target dose not reached | 125 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Target dose not reached | 109 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Dose not available | 0 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Dose not available | 2 Participants |
| Improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Target dose reached | 77 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Dose not available | 0 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Target dose reached | 30 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Target dose not reached | 49 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Dose not available | 1 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 90 | Dose not available | 0 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Dose not available | 0 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Target dose reached | 19 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Target dose not reached | 60 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Target dose reached | 30 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 180 | Dose not available | 0 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Target dose reached | 16 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Target dose not reached | 63 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Target dose reached | 22 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose beta-blocker at Day 90 | Dose not available | 0 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Target dose reached | 16 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 90 | Target dose not reached | 63 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose RAS antagonist at Day 180 | Target dose not reached | 56 Participants |
| Non-improvement | Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) | Reached target dose mineralocorticoid receptor antagonist at Day 180 | Target dose not reached | 49 Participants |
Secondary
All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use
Observe the percentage of patients having sustained VT/VF arrhythmias during WCD use. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 360 days
Population: Subjects consented and enrolled into the study phase at Day 90.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Recovery | All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use | 4 Participants |
| Improvement | All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use | 1 Participants |
| Non-improvement | All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use | 0 Participants |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use | 0 Participants |
Secondary
All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use
Observe the occurrence of all sustained VT/VF arrhythmias during WCD use by event. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 360 days
Population: Subjects consented and enrolled into the study phase at Day 90.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Recovery | All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use | 5 events |
| Improvement | All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use | 1 events |
| Non-improvement | All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use | 0 events |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use | 0 events |
Secondary
Efficacy in Treating Ventricular Arrhythmias
Observe the effectiveness of the wearable cardioverter defibrillator worn by this population in treating ventricular arrhythmias. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 180 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Recovery | Efficacy in Treating Ventricular Arrhythmias | Successfully cardioverted by the wearable cardioverter defibrillator | 7 Participants |
| Early Recovery | Efficacy in Treating Ventricular Arrhythmias | Not successfully cardioverted by the wearable cardioverter defibrillator | 0 Participants |
Secondary
Healthcare utilization_length of Use
Length of stay for any hospitalization, observation, skilled nursing facility stays. All eligible study subjects reporting one of these stays were used for this analysis, and grouped by type of stay. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 360 days
Population: Events included Hospital, Observation, and skilled nursing facility stays
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Recovery | Healthcare utilization_length of Use | 3 days |
| Improvement | Healthcare utilization_length of Use | 1 days |
| Non-improvement | Healthcare utilization_length of Use | 2 days |
Secondary
Healthcare utilization_type
Healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 360 days
Population: Healthcare utilization events (emergency room visits, hospitalizations, doctor visits etc.) for all patients during the period of the study.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Early Recovery | Healthcare utilization_type | Doctor visits | 2640 Heathcare Utilization Events |
| Early Recovery | Healthcare utilization_type | Hospitalizations | 247 Heathcare Utilization Events |
| Early Recovery | Healthcare utilization_type | Emergency room visits | 125 Heathcare Utilization Events |
| Early Recovery | Healthcare utilization_type | UrgiCare visits | 21 Heathcare Utilization Events |
| Early Recovery | Healthcare utilization_type | Skilled nursing facility/rehabilitation | 16 Heathcare Utilization Events |
| Early Recovery | Healthcare utilization_type | Observational stay | 81 Heathcare Utilization Events |
Secondary
Mortality Analysis
Evaluate the effect of wearable defibrillators on 180, 270, and 360-day mortality following discharge in HF patients. Cumulative assessment of survival will be made at these time points for those entered into the study (e.g. up to 180, 270, 360 days, or \>360 days (up to 14 months)). A mortality review will be conducted by independent adjudicators to group all deaths as cardiac or non-cardiac, and sudden or non-sudden. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. Data collected on deaths after the prespecified final timepoint (n=3) will be labeled \>360 days (up to 14 months). 1 subject completed the study immediately prior to the reported death, hence the different number from the participant flow.
Time frame: 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months)
Population: All patients in the Study were assessed for survival at Day 180, 270, and 360, or \>360 days (up to 14 months). Patients who died were adjudicated for cause of death.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Early Recovery | Mortality Analysis | 180 Day cumulative mortality | Cardiovascular death_Sudden | 2 Participants |
| Early Recovery | Mortality Analysis | 180 Day cumulative mortality | Cardiovascular death_Non sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 180 Day cumulative mortality | Non-cardiovascular death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 180 Day cumulative mortality | Non-cardiovascular death_Non Sudden | 0 Participants |
| Early Recovery | Mortality Analysis | 180 Day cumulative mortality | Unknown death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 180 Day cumulative mortality | Unknown death_Non Sudden | 0 Participants |
| Early Recovery | Mortality Analysis | 270 Day cumulative mortality | Cardiovascular death_Sudden | 2 Participants |
| Early Recovery | Mortality Analysis | 270 Day cumulative mortality | Cardiovascular death_Non sudden | 2 Participants |
| Early Recovery | Mortality Analysis | 270 Day cumulative mortality | Non-cardiovascular death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 270 Day cumulative mortality | Non-cardiovascular death_Non Sudden | 3 Participants |
| Early Recovery | Mortality Analysis | 270 Day cumulative mortality | Unknown death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 270 Day cumulative mortality | Unknown death_Non Sudden | 0 Participants |
| Early Recovery | Mortality Analysis | 360 Day cumulative mortality | Cardiovascular death_Sudden | 3 Participants |
| Early Recovery | Mortality Analysis | 360 Day cumulative mortality | Cardiovascular death_Non sudden | 2 Participants |
| Early Recovery | Mortality Analysis | 360 Day cumulative mortality | Non-cardiovascular death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 360 Day cumulative mortality | Non-cardiovascular death_Non Sudden | 6 Participants |
| Early Recovery | Mortality Analysis | 360 Day cumulative mortality | Unknown death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | 360 Day cumulative mortality | Unknown death_Non Sudden | 0 Participants |
| Early Recovery | Mortality Analysis | >360 Day cumulative mortality (up to 14 months) | Cardiovascular death_Sudden | 3 Participants |
| Early Recovery | Mortality Analysis | >360 Day cumulative mortality (up to 14 months) | Cardiovascular death_Non sudden | 2 Participants |
| Early Recovery | Mortality Analysis | >360 Day cumulative mortality (up to 14 months) | Non-cardiovascular death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | >360 Day cumulative mortality (up to 14 months) | Non-cardiovascular death_Non Sudden | 9 Participants |
| Early Recovery | Mortality Analysis | >360 Day cumulative mortality (up to 14 months) | Unknown death_Sudden | 1 Participants |
| Early Recovery | Mortality Analysis | >360 Day cumulative mortality (up to 14 months) | Unknown death_Non Sudden | 0 Participants |
Secondary
Percentage of All Patients Having Other Arrhythmias
Observe the percentage of patients having other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 180 days
Population: Subjects consented and enrolled into the study phase at Day 90.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Recovery | Percentage of All Patients Having Other Arrhythmias | Asystole | 0 Participants |
| Early Recovery | Percentage of All Patients Having Other Arrhythmias | Non-sustained ventricular tachycardia | 0 Participants |
| Early Recovery | Percentage of All Patients Having Other Arrhythmias | Supraventricular tachycardia | 13 Participants |
| Early Recovery | Percentage of All Patients Having Other Arrhythmias | Sinus tachycardia | 1 Participants |
| Improvement | Percentage of All Patients Having Other Arrhythmias | Non-sustained ventricular tachycardia | 1 Participants |
| Improvement | Percentage of All Patients Having Other Arrhythmias | Supraventricular tachycardia | 20 Participants |
| Improvement | Percentage of All Patients Having Other Arrhythmias | Sinus tachycardia | 0 Participants |
| Improvement | Percentage of All Patients Having Other Arrhythmias | Asystole | 1 Participants |
| Non-improvement | Percentage of All Patients Having Other Arrhythmias | Supraventricular tachycardia | 4 Participants |
| Non-improvement | Percentage of All Patients Having Other Arrhythmias | Non-sustained ventricular tachycardia | 2 Participants |
| Non-improvement | Percentage of All Patients Having Other Arrhythmias | Sinus tachycardia | 0 Participants |
| Non-improvement | Percentage of All Patients Having Other Arrhythmias | Asystole | 0 Participants |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | Percentage of All Patients Having Other Arrhythmias | Sinus tachycardia | 0 Participants |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | Percentage of All Patients Having Other Arrhythmias | Non-sustained ventricular tachycardia | 0 Participants |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | Percentage of All Patients Having Other Arrhythmias | Asystole | 0 Participants |
| Unassigned Based on Left Ventricular Ejection Fraction (LVEF) | Percentage of All Patients Having Other Arrhythmias | Supraventricular tachycardia | 1 Participants |
Other Pre-specified
Complications From Extended Use
The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study phase timeframe. All eligible study subjects were used for this safety analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Time frame: 360 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Recovery | Complications From Extended Use | Inappropriate shock from WCD during study phase (extended use >104 days) | 1 Participants |
| Early Recovery | Complications From Extended Use | Inappropriate shock from ICD during study phase | 0 Participants |
| Early Recovery | Complications From Extended Use | No reported inappropriate shock during study phase | 597 Participants |