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.
Study Type
OBSERVATIONAL
Enrollment
504
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
Time frame: 24 months
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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 24 months
Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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'.
Time frame: through study completion