Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 975
- Locations
- 99
- Primary Endpoint
- Heart Failure (HF) events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.