Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Device: COGNIS CRT-D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients implanted with a CRT-D (Cardiac Resynch. Therapy)<br> | Device: COGNIS CRT-D<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure (HF) events | 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. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Decompensation, Cardiac Resynchronization Therapy