CompletedNot Applicable

Protecta Smart Analysis Register

504 participantsStarted 2010-06-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 24 months

Trial details

NCT IDNCT01714921

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-01-05

Results submitted2017-09-05

View on ClinicalTrials.gov More Patients With an Indication for an ICD Implantation According to the Guidelines trials