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Completed

NCT Number: NCT01714921

Protecta Smart Analysis Register

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.

    Time frame: 24 months

    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

Secondary outcomes

  1. Number of Patients With All Smart Shock Algorithms Are Programmed on

    Time frame: 90 days or 180 days

    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.

  2. Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology

    Time frame: 24 months

    Endpoint: Patients without shock delivery due to Smart Shock technology

  3. Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.

    Time frame: 24 months

    Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD

  4. Number of Patients That Developed AT/AF

    Time frame: 24 months

    Endpoint: patients with >5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)

  5. Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.

    Time frame: At the first Follow-Up ≥ 90 days post-implant

    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

  6. Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms

    Time frame: through study completion

    Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic GmbH Germany

Registry information

Official study title

ProSA Protecta Smart Analysis Register

Acronym: ProSA

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2012
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.