Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices (MultiSENSE)
The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients|
- Heart Failure (HF) events [ Time Frame: 12 Months ] [ Designated as safety issue: No ]The primary objectives of this study are to determine how ambulatory sensor measurements change with worsening heart failure, and to develop multisensor detection algorithms. Additional data will be collected to compare sensor measurements against reference measurements when the subject is hospitalized for HF. Data from this study may also be used for determining prospective endpoints and sample sizes for future studies. There are no formal statistical primary or secondary endpoints defined for this study. Therefore, no formal tests of hypothesis will be conducted.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Patients implanted with a CRT-D (Cardiac Resynch. Therapy)||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128166
Show 99 Study Locations
|Principal Investigator:||John P Boehmer, M.D.||Milton S Hershey Medical Center, Hershey, Pennsylvania, United States|