Tachyarrhythmias
Conditions
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)
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.
Interventions
DEVICESecura ICD
Secura Implantable Cardioverter Defibrillator (ICD) will be implanted
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria, Finland, Germany, Greece, Netherlands, Saudi Arabia, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Secura Implant Patients implanted with Secura device | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Device not implanted | 1 |
Baseline characteristics
| Characteristic | Secura Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 10.45 |
| Region of Enrollment Austria | 10 participants |
| Region of Enrollment Finland | 3 participants |
| Region of Enrollment Germany | 48 participants |
| Region of Enrollment Greece | 4 participants |
| Region of Enrollment Netherlands | 10 participants |
| Region of Enrollment Saudi Arabia | 3 participants |
| Region of Enrollment Sweden | 3 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 63 Participants |
Outcome results
Primary
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Secura Implant | Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. | 0 percentage of patients |
Comparison: 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.
Secondary
Adverse Events
Number of Adverse Events reported in the implanted subjects.
Time frame: 1 Month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secura Implant | Adverse Events | 62 adverse events |
Secondary
System Performance Assessed by Holter Records
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
Population: All implanted participants underwent Holter recording. The first 21 Holter recordings that were successful were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secura Implant | System Performance Assessed by Holter Records | 0 anomalous or unintended operation |
Secondary
System Performance Assessed by Save to Disk Files
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
Population: Save to Disk files were collected for all participants implanted with a Secura ICD after implant and 1 month follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secura Implant | System Performance Assessed by Save to Disk Files | 0 anomolous or unintended device operation |
Secondary
System Performance Assessed by Technical Observations
Reported technical observations will be reviewed to determine if there are any device performance issues.
Time frame: 1 month follow-up
Population: One (1) technical observation was reported in the 79 participants that were implanted with a Secura ICD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secura Implant | System Performance Assessed by Technical Observations | 0 device performance issues |