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This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF <30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF < 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All LifeVest Users | Patients who were prescribed and used a LifeVest in France |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Cardioverter Defibrillator | Device | A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate Shock Events Per Patient | Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered. | start to end of WCD use (3 months typical prescription) |
| Risk of Not Receiving Appropriate Shocks When Necessary | While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence. | from start to end of WCD use (3 months typical prescription) |
| Inappropriate Shock Events Per Patient | Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered. | from start to end of WCD use (3 months typical prescription) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival During WCD Use | The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest | from start to end of WCD use (3 months typical prescription) |
| Quality of Life Relative to Health State |
| Measure | Description | Time Frame |
|---|---|---|
| Causes of Mortality | Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular. | Duration of prescribed device use, up to 3 months. |
| Deaths While Wearing the WCD |
Inclusion Criteria:
Patients receiving a LifeVest prescription in clinical routine for the following indications:
Patients who have given their consent to participate.
Exclusion Criteria:
- There are no exclusion criteria for this study
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Residents of France All patient who were prescribed a LifeVest were approached for consent. In addition to those prospectively enrolled, patients who had completed LifeVest use prior to the study start were eligible for retrospective enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Steve Szymkiewicz, MD | Zoll Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | France | ||||
| Clinique PASTEUR |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37021342 | Derived | Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E; WEARIT-France Investigators. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace. 2023 May 19;25(5):euad062. doi: 10.1093/europace/euad062. | |
| 33257972 |
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All LifeVest users completing use between May 2014 and December 2016 were approached for retrospective enrollment.
All patients prescribed a LifeVest January 2017 through March 2018 were approached for prospective enrollment.
Recruitment took place in France at 88 cardiology centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | WCD Users | Patients prescribed a wearable cardioverter defibrillator for:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All LifeVest Users | Patients who were prescribed and used a LifeVest in France Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Appropriate Shock Events Per Patient | Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered. | Posted | Count of Participants | Participants | start to end of WCD use (3 months typical prescription) |
|
Data was collected until the end of the prescribed WCD use time (typically 3 months).
Only serious adverse events considered related to device use were collected. Adverse events were defined as serious if it resulted in life-threatening injury/illness, required medical/surgical intervention to prevent life-threatening injury/illness or permanent impairment, required hospitalization, prolonged a hospital stay, was considered a medically important event, or resulted in death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All LifeVest Users | Patients who were prescribed and used a LifeVest in France Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inappropriate shocks | Product Issues | Systematic Assessment | Shocked without clinical VT or VF resulting in hospitalization or other medical intervention |
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Observational study. Included retrospective subjects (54%). Multiple criteria for inclusion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Osz | Zoll | 412-968-3333 | mosz@zoll.com |
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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 | Oct 10, 2016 | Jul 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D018487 | Ventricular Dysfunction, Left |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 |
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|
Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life. Agreement score according to 5-point Likert scale (lower is better):
|
| Time of enrollment |
Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes.
| Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication. |
| Toulouse |
| France |
| Derived |
| Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Enrollment type | Count of Participants | Participants |
|
| BMI | Body mass index expressed as (weight in kilograms) divided by (height in meters) squared | Missing either height or weight information on 21 subjects | Mean | Standard Deviation | kilograms per meter squared |
|
| Resting HR | Resting heart rate as assessed by clinic personnel | Missing data on 17 subjects | Mean | Standard Deviation | beats per minute |
|
| Indication for use | Indications for use were based on the reimbursement policy of France at the time of the study | Count of Participants | Participants |
|
| LVEF (4 groups) | Missing data on 8 subjects | Count of Participants | Participants |
|
| LVEF (3 groups) | Missing data on 8 subjects | Count of Participants | Participants |
|
| NYHA class | Class I: No limitation of physical activity. Class II: Slight limitation of physical activity due to heart failure symptoms. Class III: Marked limitation of physical activity due to heart failure symptoms. Class IV: Symptoms of heart failure at rest. | Missing information on 360 subjects | Count of Participants | Participants |
|
|
|
|
| Primary | Risk of Not Receiving Appropriate Shocks When Necessary | While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence. | All recorded occurrences of VF or sustained VT (>30 seconds) | Posted | Count of Units | Recorded instances of VT/VF | from start to end of WCD use (3 months typical prescription) | Recorded instances of VT/VF | Recorded instances of VT/VF |
|
|
|
| Primary | Inappropriate Shock Events Per Patient | Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered. | Posted | Count of Participants | Participants | from start to end of WCD use (3 months typical prescription) |
|
|
|
|
| Secondary | Survival During WCD Use | The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest | Posted | Count of Participants | Participants | from start to end of WCD use (3 months typical prescription) |
|
|
|
| Secondary | Quality of Life Relative to Health State | Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life. Agreement score according to 5-point Likert scale (lower is better):
| Data was collected from prospectively enrolled subjects at selected sites. Not all sites participated in the quality of life surveys. Responses were available from 246 of the 529 prospectively enrolled subjects. | Posted | Mean | Standard Deviation | units on a scale | Time of enrollment |
|
|
|
| Other Pre-specified | Causes of Mortality | Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular. | Subjects who died during the device prescription period. The prescriptive period ranged from 1 to 3 months. One death had no information recorded (retrospective group) and was labeled unknown. | Posted | Count of Participants | Participants | Duration of prescribed device use, up to 3 months. |
|
|
|
| Other Pre-specified | Deaths While Wearing the WCD | Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes. | Posted | Count of Participants | Participants | Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication. |
|
|
|
| 26 |
| 1,157 |
| 6 |
| 1,157 |
| 0 |
| 1,157 |
|
| Allergy | Skin and subcutaneous tissue disorders | Systematic Assessment | An allergy to a constituent of the LifeVest considered as medically important and required hospital stay. This was resolved. |
|
| Dyspnea with device alerts | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Paroxysmal dyspnea and LifeVest arrhythmia alerts resulted in hospital admission until resolved. |
|
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| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018754 | Ventricular Dysfunction |
| Title | Measurements |
|---|---|
|
|
| I sleep significantly better knowing I am protected by the LifeVest |
|
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| I feel more confident returning to my normal daily activities when wearing the LifeVest |
|
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| LifeVest has given me the confidence to perform exercise or cardiac rehabilitation |
|
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| Wearing the LifeVest makes me take my condition seriously |
|
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| I take significantly better care of myself since being prescribed the LifeVest |
|
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| I follow lifestyle modification recommendations from my physician |
|
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| I would recommend LifeVest to family or friends with a similar medical condition |
|
|
| Unknown (no information available) |
|