Protecta Smart Analysis Register (ProSA)

Medtronic

Status: Completed

Conditions: Patients With an Indication for an ICD Implantation According to the Guidelines

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01714921

CEN_G_CA_13

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

504 participants in 1 patient group

ICD patients

Description:

Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product