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Protecta Smart Analysis Register (ProSA)

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ClinicalTrials.gov Identifier: NCT01714921
Recruitment Status : Unknown
Verified April 2015 by Medtronic Bakken Research Center.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2012
Last Update Posted : April 23, 2015
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Brief Summary:
Examination of application and efficacy of Smart Shock algorithm in ICD patients

Condition or disease
Focus of Study is Efficacy of Smart Shock Algorithm in ICD Patients

Study Type : Observational
Estimated Enrollment : 428 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ProSA Protecta Smart Analysis Register
Study Start Date : July 2011
Primary Completion Date : September 2014
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Smart shock technology

Primary Outcome Measures :
  1. Determine the relative reduction of shock related episodes with Smart shock technology [ Time Frame: 24 months ]
    Effectiveness will be measured by the aim of Smart Shock algorithms: the reduction of shocks. Utilisation will be measured by the programming of Smart Shock algorithms and detection of tachycardia, the deviance from nominal parameters and the application of Smart Shock algorithms. To get impression of the necessarity for ICD therapy in these patients, the risk of ventricular and atrial arrhythmia will be examined in the patient population included in the study. To determine the effect of Smart Shock technology, the relative fraction of episodes which are not treated by shock delivery due to Smart Shock, will be measured. It is assumed, that a total 95% confidence interval of 10% is sufficient from a medical point of view.

Secondary Outcome Measures :
  1. evaluation of relative shock reduction due to Smart shock technology [ Time Frame: 24 months ]
  2. Number of VF episodes [ Time Frame: 24 months ]
  3. number of not known AT/AF, [ Time Frame: 24 months ]
  4. programming vs. nominal parameters dependant of baseline data [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that suffuse the inclusion criteria and signed the informed consent

Inclusion Criteria:

  • patients implanted an Implantable Cardioverter Defibrillator (ICD) with smart shock algorithm
  • written informed consent

Exclusion Criteria:

  • patients with life expectancy less than 24 months
  • patients younger than 18 years
  • pregnant or breast feeding women

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01714921     History of Changes
Other Study ID Numbers: CEN_G_CA_13
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015