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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Recovery | Patients improved to LVEF >35% within the first 90 days following GDMT. These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator (ICD) according to current guidelines. | ||
| 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. |
| |
| Non-improvement | Patients show no change, worsening of LVEF or LVEF <30%. Those on GDMT are expected to be evaluated for an ICD. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Cardioverter Defibrillator | Device | LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days |
| 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. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 360 days |
Inclusion Criteria:
Phase 1 (Registry phase)
Phase 2 (Study phase)
Exclusion Criteria (both phases):
Exclusion criteria (Phase 2)
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Patients (≥18 years old) who used a WCD for 90 days after hospitalization for a primary reason of new onset HF with ischemic or nonischemic cardiomyopathy.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Osz | Director, Clinical Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Division of Cardiovascular Disease | Birmingham | Alabama | 35294 | United States | ||
| Study Site |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Recovery | Patients improved to LVEF >35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end wearable cardioverter defibrillator (WCD) use and not receive an implantable cardioverter defibrillator (ICD) according to current guidelines. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2020 |
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|
| 360 days |
| 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. | 360 days |
| 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. | 180 days |
| 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. | 180 days |
| 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. | 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months) |
| 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. | 360 days |
| 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. | 360 days |
| West Hills |
| California |
| 91307 |
| United States |
| Baptist Heart Specialists | Fernandina Beach | Florida | 32034 | United States |
| Baptist Heart Specialists | Jacksonville | Florida | 32207 | United States |
| Baptist Heart Specialists | Jacksonville Beach | Florida | 32250 | United States |
| Institute of Cardiovascular Research | Ocala | Florida | 34471 | United States |
| Research Physicians Network Alliance | Orlando | Florida | 32825 | United States |
| Study Site | St. Petersburg | Florida | 33709 | United States |
| Fox Valley Clinical Research Center | Aurora | Illinois | 60506 | United States |
| Chicago Medical Research, LLC | Hazel Crest | Illinois | 60429 | United States |
| Unity Point Health-Methodist | Peoria | Illinois | 61602 | United States |
| Cardiovascular Research of Northwest Indiana, LLC | Munster | Indiana | 46321 | United States |
| Beacon Medical Group clinical Research | South Bend | Indiana | 26554 | United States |
| Saint Joseph London | London | Kentucky | 40741 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Covenant Medical Center, Inc. | Saginaw | Michigan | 48602 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| SSM Health Heart & Vascular | Lake Saint Louis | Missouri | 63367 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Hackensack Meridian Health | Hackensack | New Jersey | 07601 | United States |
| AtlantiCare Regional Medical Center | Pomona | New Jersey | 08240 | United States |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | 08043 | United States |
| Trinity Medical Center | Buffalo | New York | 14215 | United States |
| SJH Cardiology | Liverpool | New York | 13088 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| City Cardiology Associates | Barberton | Ohio | 44203 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Guthrie Medical Group, P.C. | Sayre | Pennsylvania | 18840 | United States |
| Carolina Heart Specialists | Lancaster | South Carolina | 29720 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57104 | United States |
| Methodist University Hospital (MUH) and Methodist OliveBranch (MOB) | Memphis | Tennessee | 38104 | United States |
| Methodist South (MS) University Hospital | Memphis | Tennessee | 38116 | United States |
| Parkway Cardiology | Oak Ridge | Tennessee | 37830 | United States |
| Texas Health Research & Education Institute | Dallas | Texas | 75231 | United States |
| Mission Research Insitute | New Braunfels | Texas | 78130 | United States |
| Providence Health Center | Waco | Texas | 76712 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| Ordensklinikum Linz GmbH/Elisabethinen | Linz | 4020 | Austria |
| Medizinische Universitätsklinik Wien | Vienna | Austria |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France |
| CHU de Grenoble site Nord- Hopital Albert Michallon | Grenoble | 38043 | France |
| CHU de Clermont-Ferrand- Hopital Albert Michallon | Grenoble | 63003 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Amper Kliniken AG, Heliios Amper-Klinikum Dachau | Dachau | Bavaria | 85221 | Germany |
| Klinik u. Polikllinik Fur Innere Med. II Kardiologie | Regensburg | Bavaria | 93042 | Germany |
| Schwarzwald-Baar Klinik | Villingen-Schwenningen | Deutschland | 78052 | Germany |
| Elisabeth-Krankenhaus | Essen | North Rhine-Westphalia | 45138 | Germany |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Herz- und Gefäßklinik Bad Neustadt | Bad Neustadt an der Saale | 97616 | Germany |
| Asklepios Klinik Barmbek | Barmbek | 22291 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | Germany |
| St. Vinzenz Hospital | Cologne | 50733 | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | 40225 | Germany |
| UKGM, Standort Giessen | Giessen | 35392 | Germany |
| Asklepios Harzklinik Goslar | Goslar | 38642 | Germany |
| Universitatsklinikum Halle | Halle | 06120 | Germany |
| Asklepios Klinik Wandsbek | Hamburg | 22043 | Germany |
| Kardiologie, Asklepios Klinik St. Georg | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hannover | 30625 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Klinikum Ludenscheid | Lüdenscheid | 58515 | Germany |
| Katholisches Klinikum Lunen | Lünen | 44534 | Germany |
| Universitätsklinikum Ulm | Ulm | Germany |
| 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. Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator |
| FG002 | 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 (ICD). Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days. Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects consented and enrolled into the study phase at Day 90.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| History of hypertension (HTN) | Count of Participants | Participants |
| ||||||||||||||||
| History of diabetes | Count of Participants | Participants |
| ||||||||||||||||
| History of chronic obstructive pulmonary disease (COPD) | Count of Participants | Participants |
| ||||||||||||||||
| History of transient ischemic attack/Cerebrovascular accident | Count of Participants | Participants |
| ||||||||||||||||
| History of chronic kidney disease | Count of Participants | Participants |
| ||||||||||||||||
| Ischemic cardiomyopathy | Count of Participants | Participants |
| ||||||||||||||||
| Non-ischemic cardiomyopathy | Count of Participants | Participants |
| ||||||||||||||||
| Mixed cardiomyopathy | Count of Participants | Participants |
| ||||||||||||||||
| History of sudden cardiac arrest | Count of Participants | Participants |
| ||||||||||||||||
| History of arrhythmia in past year | Count of Participants | Participants |
| ||||||||||||||||
| Initial heart rate | Mean | Standard Deviation | Beats per minute |
| |||||||||||||||
| Initial respiration rate | Mean | Standard Deviation | Breaths per minute |
| |||||||||||||||
| History of myocardial infarction | Count of Participants | Participants |
| ||||||||||||||||
| History of coronary artery bypass graft surgery | Count of Participants | Participants |
| ||||||||||||||||
| History of percutaneous coronary intervention | Count of Participants | Participants |
| ||||||||||||||||
| New York Heart Association (NYHA) functional class at index hospitalization | The New York Heart Association (NYHA) Functional Classification places patients in 1 of 4 categories based on limitations of physical activity. The healthcare practitioner assigns the patient at baseline and then again at follow-ups. I= No limitation of physical activity. II= Slight limitation of physical activity. III= Marked limitation of physical activity. IV= Symptoms of heart failure at rest- Any physical activity causes further discomfort. | Count of Participants | Participants |
| |||||||||||||||
| New York Heart Association (NYHA) functional class at registry start | The New York Heart Association (NYHA) Functional Classification places patients in 1 of 4 categories based on limitations of physical activity. The healthcare practitioner assigns the patient at baseline and then again at follow-ups. I= No limitation of physical activity. II= Slight limitation of physical activity. III= Marked limitation of physical activity. IV= Symptoms of heart failure at rest- Any physical activity causes further discomfort. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects with all three LVEF measurements (baseline, day 90, day 180) were analyzed. | Posted | Count of Participants | Participants | 180 days |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | Subjects with all three LVEF measurements (baseline, day 90, day 180) were analyzed. | Posted | Count of Participants | Participants | 180 days |
| ||||||||||||||||||||||||||||||||||||
| 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. | Subjects consented and enrolled into the study phase at Day 90. | Posted | Count of Participants | Participants | 360 days |
| ||||||||||||||||||||||||||||||||||||
| 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. | Subjects consented and enrolled into the study phase at Day 90. | Posted | Number | events | 360 days |
| ||||||||||||||||||||||||||||||||||||
| 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. | Subjects consented and enrolled into the study phase at Day 90. | Posted | Count of Participants | Participants | 180 days |
| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 180 days |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months) |
|
| |||||||||||||||||||||||||||||||||||
| 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. | Healthcare utilization events (emergency room visits, hospitalizations, doctor visits etc.) for all patients during the period of the study. | Posted | Count of Units | Heathcare Utilization Events | 360 days | Heathcare Utilization Events | Heathcare Utilization Events |
|
| |||||||||||||||||||||||||||||||||
| 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. | Events included Hospital, Observation, and skilled nursing facility stays | Posted | Median | Full Range | days | 360 days | Heathcare Utilization Events | Heathcare Utilization Events |
| |||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 360 days |
|
|
All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study.
Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear.
Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 5 | 279 | 0 | 279 | 8 | 279 |
| EG001 | 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. | 4 | 214 | 1 | 214 | 14 | 214 |
| EG002 | 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. | 6 | 90 | 0 | 90 | 3 | 90 |
| EG003 | 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 | 1 | 19 | 0 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asystole with Inappropriate shock | Cardiac disorders | Systematic Assessment | Inappropriate shock during asystole, occurring with hospitalization or death. Anticipated ADE. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation with LifeVest |
| |
| Discomfort | Product Issues | Systematic Assessment | Discomfort or pain from WCD |
| |
| Inappropriate shock | Product Issues | Systematic Assessment | Inappropriate shock. Anticipated ADE |
| |
| Frustration | Product Issues | Systematic Assessment | Frustration with alarms. Anticipated ADE |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Bianco | ZOLL | 4129683333 | 14410 | nbianco@zoll.com |
| Jan 23, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Asian |
|
| Caucasian |
|
| Hispanic or Latin |
|
| Black or African American |
|
| Other |
|
| No response |
|
| Multiple races selected |
|
| United States |
|
| France |
|
| Germany |
|
| Atrial fibrillation |
|
| Sinus tachycardia |
|
| Supraventricular tachycardia |
|
| Ventricular tachycardia |
|
| Ventricular fibrillation |
|
| Ventricular tachycardia (non-sustained |
|
| Sinus bradycardia |
|
| First-degree AV block |
|
| Type I Second-degree AV block |
|
| Type II Second-degree AV block |
|
| Third degree AV block |
|
| Paced rhythm |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Not documented |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Not documented |
|
| Day 180 LVEF |
|
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
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|
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.
| OG003 | 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. |
|
|
|
|
|
| Heathcare Utilization Events |
|
|
| Units | Counts |
|---|
| Participants |
|
| Heathcare Utilization Events |
|
|
|
| Dose not available |
|
| Dose not available |
|
| Dose not available |
|
| Dose not available |
|
| Dose not available |
|
|
| Non-cardiovascular death_Non Sudden |
|
| Unknown death_Sudden |
|
| Unknown death_Non Sudden |
|
|
| Non-cardiovascular death_Non Sudden |
|
| Unknown death_Sudden |
|
| Unknown death_Non Sudden |
|
|
| Non-cardiovascular death_Non Sudden |
|
| Unknown death_Sudden |
|
| Unknown death_Non Sudden |
|