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| Name | Class |
|---|---|
| Medtronic GmbH Germany | UNKNOWN |
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ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent following product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD patients | Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product |
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| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. | Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients. Endpoints for the primary objective:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With All Smart Shock Algorithms Are Programmed on | Endpoint: Patients, in which none of the Smart Shock algorithms is programmed "OFF" during the first Follow-Up after a maximum length of 90 days and 180 days. | 90 days or 180 days |
| Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that satisfy the inclusion criteria and signed the informed consent
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504 patients were enrolled at 29 German sites between 09-Jun-2010 and 22-Oct-2012
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| ID | Title | Description |
|---|---|---|
| FG000 | ICD Patients (Single Arm Study) | Patients with an indication for an Implantable Cardioverter/Defibrillator (ICD) implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ICD Patients | Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. | Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients. Endpoints for the primary objective:
| The change of episodes of episodes inappropriately treated by shock due to Smart Shock™ was calculated as follow: change of episodes= (Episodes without shock therapy due to Smart Shock™)/(total number of episodes) | Posted | Number | % of episodes wo shock due to SmartShock | 24 months | total number of episodes | total number of episodes |
|
All devices that were used in this study are market-released and were only used within their approved indication. Therefore vigilance reporting was performed in the context of Post Market Surveillance. Adverse event information was therefore not collected during this study.
All devices that were used in this study are market-released and were only used within their approved indication. Therefore vigilance reporting was performed in the context of Post Market Surveillance. Adverse event information was therefore not collected during this study.
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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 | ICD Patients (Single Arm Study) | Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ProSA clinical research contact | Medtronic GmbH | 004921598149 | 0 | rs.dusclinicalcooperation@medtronic.com |
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Endpoint: Patients without shock delivery due to Smart Shock technology |
| 24 months |
| Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes. | Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD | 24 months |
| Number of Patients That Developed AT/AF | Endpoint: patients with >5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass) | 24 months |
| Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming. | Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant. Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:
Nominals for single chamber ICDs:
| At the first Follow-Up ≥ 90 days post-implant |
| Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms | Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'. | through study completion |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| ICD Patients (Single Arm Study) |
Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product |
|
|
| Secondary | Number of Patients With All Smart Shock Algorithms Are Programmed on | Endpoint: Patients, in which none of the Smart Shock algorithms is programmed "OFF" during the first Follow-Up after a maximum length of 90 days and 180 days. | Patients with data available at 90 days | Posted | Count of Participants | Participants | 90 days or 180 days |
|
|
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| Secondary | Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology | Endpoint: Patients without shock delivery due to Smart Shock technology | Posted | Number | pat. w. at least 1 shock prevented in % | 24 months |
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|
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| Secondary | Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes. | Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD | Of all 272 patients with primary preventive indication, only 265 patients had device data available for the Follow-Up period. | Posted | Count of Participants | Participants | 24 months |
|
|
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| Secondary | Number of Patients That Developed AT/AF | Endpoint: patients with >5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass) | Out of all patients analyzed (N=504), the patients with Single-Chamber-ICDs were excluded as these devices had no feature to identify AT/AF. This lead to N=367. Out of these 367 patients only 337 had Follow-Up data available whereas 30 patients only had implant data. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming. | Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant. Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:
Nominals for single chamber ICDs:
| Posted | Count of Participants | Participants | At the first Follow-Up ≥ 90 days post-implant |
|
|
|
| Secondary | Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms | Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'. | In total, 71 episodes were detected by the device and classified as T-wave Oversensing or Noise, but only 20 had electrogram (EGM) strips available. The analysis of the positive predictive value (PPV) was performed on these 20 episodes only. The number of true positives was 20. The number of false positives was 0. | Posted | Number | Positive Predictive Value in % | through study completion | episodes with EGM strips | episodes with EGM strips |
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| 0 |
| 0 |
| 0 |
| 0 |
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