Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

Completed

• Conditions: Heart Failure

• Registration Number: NCT01128166
• Lead Sponsor: Boston Scientific Corporation

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 Timeline

• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Study Start: 2010-06
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 975

Inclusion Criteria

• Age 18 or above, or of legal age to give informed consent specific to state and national law
• Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate
• Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center
• Currently implanted with a COGNIS device (Model N119 or N120, P107, P108)
• Classified as NYHA Class II, III or IV within the last six months

Exclusion Criteria

• Inability or refusal to sign the Subject Informed Consent
• Inability of refusal to comply with the follow-up schedule
• Documented as pacemaker dependent
• Unable to rest comfortably in a semi-recumbent position for up to 20 minutes
• Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949
• Currently implanted with unipolar RA, RV, or LV leads
• LV sensitivity programmed to less than 0.7 mV AGC
• History of appropriate tachycardia therapy (external or implanted) for rates < 165 bpm within 1 week prior to enrollment
• Device battery status indicates approximate time to explant < 2 years
• Likely to undergo lead or PG revision during the course of the study as determined by the investigator
• Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen
• Have received heart or lung transplant
• Receiving mechanical circulatory support
• Patients who have been referred or admitted for Hospice care
• A life expectancy of less than 12 months per physician discretion
• Enrolled in any concurrent study without Boston Scientific written approval
• Devices previously converted to the SRD-1 and withdrawn from the study
• Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol
• Known pregnancy or plan to become pregnant within the course of the study
• LV offset is programmed to a value greater than zero

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Failure (HF) events	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.

Trial Locations

Locations (99)

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

Arizona Advanced Arrhythmias; 🇺🇸 Gilbert, Arizona, United States

Baptist Health Medical Center; 🇺🇸 Little Rock, Arizona, United States

Tri-City Cardiology; 🇺🇸 Mesa, Arizona, United States

Cardiovascular Consultants, LTD; 🇺🇸 Phoenix, Arizona, United States

Pima Heart Physicians, PC; 🇺🇸 Tucson, Arizona, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Cardiology Associates of Northeast Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

LAC & USC Medical Center; 🇺🇸 Los Angeles, California, United States

John Muir Medical Center; 🇺🇸 Oakland, California, United States

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