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Protecta Smart Analysis Register (ProSA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01714921
First received: October 16, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of VF episodes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • number of not known AT/AF, [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • programming vs. nominal parameters dependant of baseline data [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01714921     History of Changes
Other Study ID Numbers: CEN_G_CA_13
Study First Received: October 16, 2012
Last Updated: October 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on June 17, 2013