Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices (MultiSENSE)
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|ClinicalTrials.gov Identifier: NCT01128166|
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : October 21, 2015
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: COGNIS CRT-D|
|Study Type :||Observational|
|Actual Enrollment :||975 participants|
|Official Title:||Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients|
|Study Start Date :||June 2010|
|Primary Completion Date :||December 2014|
|Study Completion Date :||July 2015|
|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.
- Heart Failure (HF) events [ Time Frame: 12 Months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128166
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|Principal Investigator:||John P Boehmer, M.D.||Milton S Hershey Medical Center, Hershey, Pennsylvania, United States|