NCT00957541

Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device

Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: ELA Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.

Detailed description

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	Paradym CRT + Physiological Diagnosis (PhD)	All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-04-01
• Completion: 2013-04-01
• First posted: 2009-08-12
• Last updated: 2014-05-15

Locations

1 site across 1 country: United States