Trial Outcomes & Findings for SecuraTM ICD Clinical Evaluation Study (NCT NCT00526227)
NCT ID: NCT00526227
Last Updated: 2025-07-02
Results Overview
Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days. A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis.
COMPLETED
NA
81 participants
1 month
2025-07-02
Participant Flow
Participant milestones
| Measure |
Secura ICD Implant
Participants were implanted with a Secura Implantable Cardiac Defibrillator (ICD)
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
79
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Secura ICD Implant
Participants were implanted with a Secura Implantable Cardiac Defibrillator (ICD)
|
|---|---|
|
Overall Study
Device not implanted
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
SecuraTM ICD Clinical Evaluation Study
Baseline characteristics by cohort
| Measure |
Secura Implant
n=81 Participants
Patients implanted with Secura device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Forty-four (44) out of the 80 subjects completed at least one-month (28 days) of follow-up post-implant and were included in the (interim) analysis for the primary objective. One subject of the 80 implanted subjects died prior to the 1-month follow-up.
Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days. A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis.
Outcome measures
| Measure |
Secura Implant
n=44 Participants
Patients implanted with a Secura device
|
|---|---|
|
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
|
0 percentage of patients
Interval 0.0 to 7.7
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All implanted participants underwent Holter recording. The first 21 Holter recordings that were successful were analyzed.
The first 21 digital Holter records that were successfully collected in the total of 80 implanted participants will summarize any anomalous or unintended operation and describe device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Outcome measures
| Measure |
Secura Implant
n=21 Holter recordings
Patients implanted with a Secura device
|
|---|---|
|
System Performance Assessed by Holter Records
|
0 anomalous or unintended operation
|
SECONDARY outcome
Timeframe: 1 MonthNumber of Adverse Events reported in the implanted subjects.
Outcome measures
| Measure |
Secura Implant
n=79 Participants
Patients implanted with a Secura device
|
|---|---|
|
Adverse Events
|
62 adverse events
|
SECONDARY outcome
Timeframe: 1 month follow-upPopulation: Save to Disk files were collected for all participants implanted with a Secura ICD after implant and 1 month follow up.
The Save to Disk files from 79 implanted participants collected after implant and 1 month follow up were reviewed to identify any anomolous or unintended device operation, examine device features, observe ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Outcome measures
| Measure |
Secura Implant
n=79 Participants
Patients implanted with a Secura device
|
|---|---|
|
System Performance Assessed by Save to Disk Files
|
0 anomolous or unintended device operation
|
SECONDARY outcome
Timeframe: 1 month follow-upPopulation: One (1) technical observation was reported in the 79 participants that were implanted with a Secura ICD.
Reported technical observations will be reviewed to determine if there are any device performance issues.
Outcome measures
| Measure |
Secura Implant
n=1 Reported Technical Observations
Patients implanted with a Secura device
|
|---|---|
|
System Performance Assessed by Technical Observations
|
0 device performance issues
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether Confidential Information (CI) is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
- Publication restrictions are in place
Restriction type: OTHER