This trial is active, not recruiting.

Condition focus of study is efficacy of smart shock algorithm in icd patients
Sponsor Medtronic Bakken Research Center
Collaborator Medtronic
Start date July 2011
End date September 2014
Trial size 428 participants
Trial identifier NCT01714921, CEN_G_CA_13


Examination of application and efficacy of Smart Shock algorithm in ICD patients

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Determine the relative reduction of shock related episodes with Smart shock technology
time frame: 24 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title ProSA Protecta Smart Analysis Register
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Medtronic Bakken Research Center.