Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE)

Completed

Conditions: heart Fialure
10019280

Registration Number: NL-OMON37715

Lead Sponsor: Boston Scientific

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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 CRT-D system including a COGNIS device (Model N119, N120, P107 or P108) with RA, RV, and LV leads;Classified as NYHA Class II, III, or IV within the last 6 months

Exclusion Criteria

Inability or refusal to sign the Patient Informed Consent
Inability or 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 <0.7mV AGC
Subjects that have a 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>It is estimated that approximately 100 events will be required for developing a<br /><br>multisensory algorithm for the early detection of HF events. </p><br>

Secondary Outcome Measures