N/A
Completed N=504
Protecta Smart Analysis Register
Patients With an Indication for an ICD Implantation According to the Guidelines
Source: ClinicalTrials.gov NCT01714921 ↗
Enrolled (actual)
504
Serious AEs
—
Results posted
Nov 2018
Primary outcomePrimary: Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. — 94.9 % of episodes wo shock due to SmartShock
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. |
94.9 | — |
| SECONDARY Number of Patients With All Smart Shock Algorithms Are Programmed on |
300 | — |
| SECONDARY Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology |
15.3 | — |
| SECONDARY Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes. |
15 | — |
| SECONDARY Number of Patients That Developed AT/AF |
117 | — |
| SECONDARY Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming. |
421 | — |
| SECONDARY Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms |
100 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01714921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.