Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming

Medtronic

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: Therapy Programming Report (TPR)

Study type: Observational

Funder types: Industry

Identifiers

NCT00856349

Shock-Less

Details and patient eligibility

About

The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for defibrillators.

Full description

Shocks delivered to patients by defibrillators, while life-saving, can create anxiety, pain and decrease quality of life. Previous studies have shown that device programming and features can safely reduce the number of shocks patients receive. This study will explore the extent to which physicians use these programming and features. It will determine whether repeat and frequent awareness to how they program their own subjects and the programming trends of all enrolled subjects will change their programming patterns. This will be accomplished by understanding physicians' device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.

Enrollment: 4,384 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Consent Form (PCF) and authorization for access to and use of health information, if applicable
• Subject has been implanted with a Medtronic market released ICD or CRT-D device (US/Canada - Concerto®/Virtuoso® or newer model; AsiaPacific, Israel, Latin America - EnTrust™, InSync Sentry®, or Concerto®/Virtuoso® or newer model) within the past 30 days
• Subject has commercially released RA (if applicable), RV, and LV (if applicable) leads

Exclusion criteria

• Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader

Trial design

4,384 participants in 1 patient group

Analysis cohort

Description:

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Treatment:

Behavioral: Therapy Programming Report (TPR)