NCT01128166

Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 975 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

Detailed description

The purpose of MultiSENSE study is to collect data about patient events during worsening heart failure, determine how sensor measurements vary during patient daily activities and during the development and recovery from events of worsening heart failure, develop algorithms capable of detecting the onset of worsening heart failure prior to the overt presentation of patient symptoms using reference measurements: thoracic impedance, heart sounds, physiologic responses to activities and respiration.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	COGNIS CRT-D	Patients with existing or newly implanted COGNIS® CRT-D pulse generators (PG)are enrolled in the study. PG is modified by the download of investigational software called Sensor Research Device-1™ (SRD-1). The goal of the SRD-1 system is to collect sensor data without affecting the delivered CRT-D therapy. This is accomplished through the "conversion" of an implanted COGNIS PG into a SRD-1 PG by downloading investigational software. Only a market approved COGNIS model N119/N120/P107/P108 device may be converted to a SRD-1 investigational device. There will be no PG hardware changes resulting from the conversion.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2010-05-21
• Last updated: 2015-10-21

Locations

99 sites across 12 countries: United States, Czechia, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Netherlands, Slovakia, Thailand, United Kingdom