SecuraTM ICD Clinical Evaluation Study
Study Details
Study Description
Brief Summary
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics.
The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), Unscheduled Follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Secura ICD implant Secura ICD device implanted |
Device: Secura ICD
Secura Implantable Cardioverter Defibrillator (ICD) will be implanted
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. [1 month]
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.
Secondary Outcome Measures
- System Performance Assessed by Holter Records [1 month]
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.
- Adverse Events [1 Month]
Number of Adverse Events reported in the implanted subjects.
- System Performance Assessed by Save to Disk Files [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.
- System Performance Assessed by Technical Observations [1 month follow-up]
Reported technical observations will be reviewed to determine if there are any device performance issues.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who have an ICD indication.
-
Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
-
Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.
Exclusion Criteria:
-
Patients with a life expectancy less than the duration of the study.
-
Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
-
Patients with mechanical tricuspid heart valves.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wels | Austria | |||
| 2 | Tampere | Finland | |||
| 3 | Goettigen | Germany | |||
| 4 | Hannover | Germany | |||
| 5 | Homburg/Saar | Germany | |||
| 6 | Kaiserslautern | Germany | |||
| 7 | Luedenscheid | Germany | |||
| 8 | Muenster | Germany | |||
| 9 | Athens | Greece | |||
| 10 | Breda | Netherlands | |||
| 11 | Enschede | Netherlands | |||
| 12 | Riyadh | Saudi Arabia | |||
| 13 | Lund | Sweden |
Sponsors and Collaborators
- Medtronic Bakken Research Center
Investigators
- Study Chair: Secura Clinical Study Team, Medtronic Bakken Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 111
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Secura ICD Implant |
|---|---|
| Arm/Group Description | Participants were implanted with a Secura Implantable Cardiac Defibrillator (ICD) |
| Period Title: Overall Study | |
| STARTED | 81 |
| COMPLETED | 79 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Secura Implant |
|---|---|
| Arm/Group Description | Patients implanted with Secura device |
| Overall Participants | 81 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
42
51.9%
|
| >=65 years |
39
48.1%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.4
(10.45)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
18
22.2%
|
| Male |
63
77.8%
|
| Region of Enrollment (participants) [Number] | |
| Austria |
10
12.3%
|
| Germany |
48
59.3%
|
| Netherlands |
10
12.3%
|
| Greece |
4
4.9%
|
| Saudi Arabia |
3
3.7%
|
| Finland |
3
3.7%
|
| Sweden |
3
3.7%
|
Outcome Measures
| Title | Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. |
|---|---|
| Description | 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. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Secura Implant |
|---|---|
| Arm/Group Description | Patients implanted with a Secura device |
| Measure Participants | 44 |
| Number (97.5% Confidence Interval) [percentage of patients] |
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Secura Implant |
|---|---|---|
| Comments | H 0 (null hypothesis): P ≥ 10%; H A (alternative hypothesis): P < 10%, where P is the percentage of subjects experiencing a USADE through the 1-month post implant. An upper limit of the confidence interval of the percentage subjects with USADE not greater than or equal to 10% at the 1-month follow-up visit provides a reasonably-sized clinical study with sufficient power to detect USADEs. | |
| Type of Statistical Test | Other | |
| Comments | An exact one-sided 97% upper confidence bound or a p-value will be calculated based on the observed percentage of subjects with an USADE within the first month post-implant. This rate will be considered acceptable if the one-sided 97% upper confidence bound is less than 10% or, equivalently, if the p-value is less than 0.0304. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage |
| Estimated Value | 7.7 | |
| Confidence Interval |
(1-Sided) 97% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The CI was calculated based on 44 patients at interim analysis: 0 USADE were reported within 1-month post implant, ie 0% of subjects experienced a USADE. The one-sided 97% exact binomial upper confidence bound was 7.7% which is lower than 10%. | |
| Title | System Performance Assessed by Holter Records |
|---|---|
| Description | 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. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| All implanted participants underwent Holter recording. The first 21 Holter recordings that were successful were analyzed. |
| Arm/Group Title | Secura Implant |
|---|---|
| Arm/Group Description | The first 21 patients implanted with a Secura device that has a successful Holter recording |
| Measure Participants | 21 |
| Measure Holter recordings | 21 |
| Number [anomalous or unintended operation] |
0
|
| Title | Adverse Events |
|---|---|
| Description | Number of Adverse Events reported in the implanted subjects. |
| Time Frame | 1 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Secura Implant |
|---|---|
| Arm/Group Description | Patients implanted with a Secura device |
| Measure Participants | 79 |
| Number [adverse events] |
62
|
| Title | System Performance Assessed by Save to Disk Files |
|---|---|
| Description | 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. |
| Time Frame | 1 month follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Save to Disk files were collected for all participants implanted with a Secura ICD after implant and 1 month follow up. |
| Arm/Group Title | Secura ICD Implant |
|---|---|
| Arm/Group Description | Participants were implanted with a Secura ICD |
| Measure Participants | 79 |
| Number [anomolous or unintended device operation] |
0
|
| Title | System Performance Assessed by Technical Observations |
|---|---|
| Description | Reported technical observations will be reviewed to determine if there are any device performance issues. |
| Time Frame | 1 month follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| One (1) technical observation was reported in the 79 participants that were implanted with a Secura ICD. |
| Arm/Group Title | Secura ICD Implant |
|---|---|
| Arm/Group Description | Participants were implanted with a Secura ICD |
| Measure Participants | 1 |
| Measure Reported Technical Observations | 1 |
| Number [device performance issues] |
0
|
Adverse Events
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | CRDM Core Clinical Organization |
|---|---|
| Organization | Medtronic CRDM |
| Phone | 800-328-2518 |
| jamie.l.reynolds@medtronic.com |
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