NCT00980057

Adaptive Cardiac Resynchronization Therapy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 522 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

Detailed description

The trial has 3 primary end points: * to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm * to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings * to demonstrate that aCRT does not result in inappropriate AV or VV delay settings

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Adaptive CRT (aCRT)	Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function
DEVICE	Echo	Standard BiV pacing with settings optimized using a standardized echocardiographic protocol

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-08-04
• Completion: 2012-03-08
• First posted: 2009-09-18
• Last updated: 2018-10-16
• Results posted: 2018-10-16

Locations

105 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Netherlands, Norway, Russia, Saudi Arabia, Serbia, Spain, Sweden