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Protecta Smart Analysis Register (ProSA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Medtronic Bakken Research Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714921
First Posted: October 26, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  Purpose
Examination of application and efficacy of Smart Shock algorithm in ICD patients

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ProSA Protecta Smart Analysis Register

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

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

Estimated Enrollment: 428
Study Start Date: July 2011
Estimated Study Completion Date: November 2016
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Smart shock technology

  Eligibility

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
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01714921     History of Changes
Other Study ID Numbers: CEN_G_CA_13
First Submitted: October 16, 2012
First Posted: October 26, 2012
Last Update Posted: October 12, 2017
Last Verified: April 2015