Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT01128166
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MultiSENSE
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: