|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P010030 S056/ PAS001 |
Date Original Protocol Accepted |
12/17/2015
|
Date Current Protocol Accepted |
 
|
Study Name |
PMA Post-Approval Study
|
Device Name |
LIFEVEST WEARABLE DEFIBRILLATOR
|
General Study Protocol Parameters |
Study Design |
Active Surveillance
|
Data Source |
Sponsor Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
Prospectively collect and assess device data with the patients under 18 years of age using manufacturer owned registry
|
Study Population |
The patient population will be all patients who have been prescribed the LifeVest under the proposed indication. There are no comparison groups.
|
Sample Size |
For the purpose of this data collection proposal, ZOLL will collect data on 150 patients under 18 years of age.
|
Key Study Endpoints |
The following data will be collected: a) Patient Demographics: i. Age ii. Gender iii. ICD-9 code(s) describing the patient’s condition b) Performance: i. Daily compliance with use ii. Duration of use iii. Appropriate therapy delivery, as determined by internal medically trained personnel iv. ECG recordings during appropriate therapy delivery and any available description of the circumstances found within the Call Report Database. c) Safety: i. Inappropriate defibrillation therapy delivery, as determined by internal medically trained personnel ii. ECG recordings during inappropriate therapy delivery and any available description of the circumstances found within the Call Report Database iii. Adverse events reported to ZOLL through the customer support or technical support departments
|
Follow-up Visits and Length of Follow-up |
The device will be used temporarily (days) and the data will be obtained from returned device. No actual patient followup is needed.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
273
|
Actual Number of Sites Enrolled |
N/A
|
Patient Follow-up Rate |
N/A
|
Final Safety Findings |
Adverse event rate reported as complaints: - 4 (1.47% of patients) - 0.1 AEs/patient years of wear time (4/39.5) Inappropriate Defibrillation Data: 1 shock/14,435 patient days = 0.002 inappropriate shocks/month
|
Final Effect Findings |
Only 1 appropriate shock was observed in the current study. First shock success rate: 100%.
|
Study Strengths & Weaknesses |
N/A
|
Recommendations for Labeling Changes |
Yes
|