PREcision Event Monitoring of PatienTs with Heart Failure

Completed

Conditions: cardiac arrest
congestive heart failure
10019280

Registration Number: NL-OMON48493

Lead Sponsor: Boston Scientific

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

• Subject is age 18 or above, or of legal age to give informed consent specific
to each
country and national laws
• Subject has a documented diagnosis of heart failure
• Subject has a Boston Scientific CRT-D or ICD device implant that has
HeartLogic,
with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep
Incline Sensor turned ON
• Subject has an active bipolar RV lead implant.
• Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing
to be
remotely monitored from the baseline visit for approximately 12 months with
HeartLogic disabled

Exclusion Criteria

• Subject has received or is scheduled to receive a heart transplant or
ventricular assist device (VAD).
• Subject is enrolled in any concurrent clinical study without prior
Boston Scientific written approval (excluding registries).
• Subject has a life expectancy of less than 12 months.
• Subject has a history of non-compliance to medical care or known
inability to comply with requirements of the clinical study protocol.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>The primary objective of the PREEMPT-HF study is to investigate the<br /><br>association between HF sensor data and 30-day HF readmissions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional Objectives<br /><br>1. Characterize HF sensor data for:<br /><br>o Association with risk for device VT/VF therapy<br /><br>o Phenomapping of HF events<br /><br>o Association with non-HF hospitalizations including cardiac non-HF<br /><br>events and non-cardiac events<br /><br>2. Collect subject Sleep Incline Sensor data prior to and following reviewable<br /><br>clinical events<br /><br>3. Link study data to third-party data, such as Center for Medicare and<br /><br>Medicaid Services (CMS) administrative claims (US only). Association of<br /><br>clinical study events and sensor data with other data sources will be<br /><br>investigated. Any study data linkage will abide by all applicable laws,<br /><br>regulations, and data use agreements, and patients will be consented<br /><br>accordingly.</p><br>