Protecta Smart Analysis Register

Study Overview
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Brief Summary
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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.

Official Title
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ProSA Protecta Smart Analysis Register

Conditions
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Patients With an Indication for an ICD Implantation According to the Guidelines

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients implanted with an Implantable Cardioverter Defibrillator (ICD) with the smart shock algorithm (Protecta™, Protecta™ XT or any equivalent following product) written informed consent Exclusion Criteria: patients with life expectancy less than 24 months patients younger than 18 years pregnant or breast feeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD patients<br>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Episodes with shock therapy Episodes without shock delivery due to Smart Shock™ technology Episodes classified as supraventricular tachycardia (SVT) by PR Logic Episodes classified as SVT by Wavelet Shock therapy suppressed by T-wave Discrimination Shock therapy suppressed by Lead Noise Discrimination Shock therapy suppressed by Confirmation + Episode with successful anti-tachycardia pacing (ATP) During Charging | 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: Lead Noise Discrimination = 'OnWithTimeout' Lead Failure Predictor = 'On' PR-Logic: AfibAflutter Rejection Rule = 'On' PR-Logic: Sinus Tach Rejection Rule = 'On' PR-Logic: Other 1:1 Rejection Rule = 'On' High Rate Timeout = 'Off' VF High Rate Timeout = 'Off' Wavelet Rejection Rule = 'On' VF Detection Interval = 320 and SVT Minimum Cycle Length = 260 T-Wave Oversensing Discrimination = 'On' ATP During Charging = 'DuringCharging' Nominals for single chamber ICDs: Lead Noise Discrimination = 'OnWithTimeout' Lead Failure Predictor = 'On' High Rate Timeout = 'Off' VF High Rate Timeout = '0.75 min' Wavelet Rejection Rule = 'On' VF Detection Interval = 320 and SVT Minimum Cycle Length = 260 T-Wave Oversensing D | 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 |