Heart Failure
Conditions
Keywords
Heart Failure, Decompensation, Cardiac Resynchronization Therapy
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.
Interventions
DEVICECOGNIS 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.
Sponsors
Milton S. Hershey Medical Center
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Netherlands, Slovakia, Thailand, United Kingdom, United States
Outcome results
None listed