NCT00856349

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,384 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	Therapy Programming Report (TPR)	Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study.

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-03-05
• Last updated: 2014-07-03
• Results posted: 2014-07-03

Locations

104 sites across 12 countries: United States, Argentina, Australia, Canada, China, Hong Kong, India, Mexico, New Zealand, Singapore, South Korea, Taiwan