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Lack of subject enrollment
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A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.
Objective:
To study the impact of wearable cardioverter defibrillator (WCD) use on sudden cardiac death in hemodialysis patients.
Study Population:
Participants will be patients beginning hemodialysis (<2 months from initiation) who are ≥ 50 years old.
Intervention:
A WCD will be used for protection against sudden cardiac death (SCD).
Study Design:
The study will be a multi-center, prospective, randomized controlled trial with 1:1 assignment of treatment and control.
Study Size:
The study will enroll up to 2,600 subjects. A maximum of 200 sites will be used for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable Cardioverter Defibrillator | Experimental | End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months |
|
| Conventional Treatment | No Intervention | Conventional Treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Cardioverter Defibrillator | Device | Wearable Cardioverter Defibrillator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis | This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mortality | All cause mortality | 6 months |
| Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis | This is an as-treated analysis of SCD. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wojciech Zareba, M.D., Ph.D | University of Rochester | Principal Investigator |
| Charles A. Herzog, M.D. | Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corona | California | United States | ||||
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Since the sudden death rate is highest early after initiating hemodialysis, subjects could be enrolled from 1 month before starting dialysis to 2 months after. All subjects had to have a left ventricular ejection fraction over 50%. Subjects were shown a wearable defibrillator and were anticipated to be able to use it prior to enrollment.
Recruitment for the study began on 30-Jun-2015 and ended 15-Feb-2017. Subjects beginning or anticipated to begin dialysis were recruited from kidney clinics and dialysis centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wearable Cardioverter Defibrillator | End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment. |
| FG001 | Conventional Treatment |
| 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 | Apr 22, 2015 |
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| 6 months |
| Clinical Status of Sudden Cardiac Arrest (SCA) Survivors | This is an intention to treat analysis of the clinical status of participants who experience an SCA and survive at least 48 hours, as determined by the Glasgow Coma Scale (numeric scale is 3 to 14, higher is better). | 48 hours after SCA |
| Incidence of Potentially Life Threatening Arrhythmias | In the Wearable Cardioverter Defibrillator arm, determine the incidence of potentially life-threatening arrhythmias while the device was worn. Life-threatening arrhythmias are defined as ventricular tachycardia over 150 beats per minute and ventricular fibrillation (VTVF). | 6 months |
| Risk of Inappropriate Therapy | Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm | 6 months |
| Compliance With Wearable Cardioverter Defibrillator Therapy | In the group randomized to receive a Wearable Cardioverter Defibrillator, the device recorded time of use will be used to determine compliance measured as a % of time available for use. | 6 months |
| Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months | A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better. | 2 months |
| Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months | A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better. | 6 months |
| Downey |
| California |
| United States |
| Escondido | California | United States |
| Los Angeles | California | United States |
| Sacramento | California | United States |
| San Dimas | California | United States |
| San Luis Obispo | California | United States |
| Whittier | California | United States |
| Stamford | Connecticut | United States |
| Hialeah | Florida | United States |
| Miami | Florida | United States |
| Pembroke Pines | Florida | United States |
| Winter Garden | Florida | United States |
| Albany | Georgia | United States |
| Columbus | Georgia | United States |
| Fort Wayne | Indiana | United States |
| Greenbelt | Maryland | United States |
| Detroit | Michigan | United States |
| Rochester Hills | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Kansas City | Missouri | United States |
| Las Vegas | Nevada | United States |
| New Brunswick | New Jersey | United States |
| The Bronx | New York | United States |
| Durham | North Carolina | United States |
| Canton | Ohio | United States |
| Greenville | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
End Stage Renal Disease (ESRD) patients beginning hemodialysis will get conventional treatment only.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wearable Cardioverter Defibrillator | End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment. |
| BG001 | Conventional Treatment | Conventional treatment during hemodialysis initiation will be applied to this arm. |
| BG002 | 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 | Data entry error on one subject in control group. | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| History of Heart Failure | Missing data on 3 WCD subjects and 1 Control subject | Count of Participants | Participants |
| |||||||||||||||
| Previous Myocardial Infarction | Missing data on 2 WCD subjects and 3 Control subjects | Count of Participants | Participants |
| |||||||||||||||
| History of Ventricular Arrhythmias | Missing data on 2 Control subjects | 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 | Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis | This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Total Mortality | All cause mortality | Posted | Count of Participants | Participants | 6 months |
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| |||||||||||||||||||||||||||||||
| Secondary | Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis | This is an as-treated analysis of SCD. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate. | To allow for crossovers, the analysis unit is patient months. Note: There were crossover months in the treatment group that were included in the control group for this as-treated analysis. That is, since all WCD users had months during which they did not use a WCD, they are also counted in the WCD not used group. | Posted | Mean | 95% Confidence Interval | patient months | 6 months | patient months | patient months |
| ||||||||||||||||||||||||||||
| Secondary | Clinical Status of Sudden Cardiac Arrest (SCA) Survivors | This is an intention to treat analysis of the clinical status of participants who experience an SCA and survive at least 48 hours, as determined by the Glasgow Coma Scale (numeric scale is 3 to 14, higher is better). | Study participants from both arms who experienced SCA. | Posted | 48 hours after SCA |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Potentially Life Threatening Arrhythmias | In the Wearable Cardioverter Defibrillator arm, determine the incidence of potentially life-threatening arrhythmias while the device was worn. Life-threatening arrhythmias are defined as ventricular tachycardia over 150 beats per minute and ventricular fibrillation (VTVF). | All subjects using a wearable cardioverter defibrillator were included (treatment group assignment and crossovers from control group assignment). Only months with wearable cardioverter defibrillator use were used for calculations. | Posted | Mean | 90% Confidence Interval | VTVF per patient-month | 6 months | patient-months | patient-months |
|
| |||||||||||||||||||||||||||
| Secondary | Risk of Inappropriate Therapy | Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm | All subjects using a wearable cardioverter defibrillator were included (treatment group assignment and crossovers from control group assignment). Only months with wearable cardioverter defibrillator use were used for calculations. | Posted | Mean | 90% Confidence Interval | inappropriate shocks per patient month | 6 months | patient months | patient months |
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| Secondary | Compliance With Wearable Cardioverter Defibrillator Therapy | In the group randomized to receive a Wearable Cardioverter Defibrillator, the device recorded time of use will be used to determine compliance measured as a % of time available for use. | All trial participants who were randomized to wear a wearable cardioverter defibrillator. | Posted | Mean | Standard Deviation | Percentage of time available for use | 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months | A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better. | All subjects completing the KDQOL-36 at 2 months. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
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| Secondary | Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months | A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better. | All subjects completing the KDQOL-36 at 6 months. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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6 months
An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
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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 | Wearable Cardioverter Defibrillator | End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment. | 0 | 29 | 0 | 29 | 5 | 29 |
| EG001 | Conventional Treatment | Conventional treatment during hemodialysis initiation will be applied to this arm. | 0 | 31 | 0 | 31 | 0 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Discomfort with wearing the device |
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| Frequent false alarms | Social circumstances | Non-systematic Assessment | study withdrawal due to self-terminating arrhythmia alarms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Zoll | 724-968-3333 | mosz@zoll.com |
| Jul 22, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D017180 | Tachycardia, Ventricular |
| 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 |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
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Time during which a wearable defibrillator was not worn, whether in the intention to treat wearable defibrillator arm (crossovers) or the control arm.
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