Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 3750
Summary
- Conditions
- Cardiac Resynchronization Therapy
- Cardiovascular Disease
- Defibrillators, Implantable
- Heart Disease
- Heart Failure
- Monitoring, Physiologic
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events, and include all-cause hospitalizations and Heart Failure outpatient visits. Clinical e...
Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events, and include all-cause hospitalizations and Heart Failure outpatient visits. Clinical event definitions are as follows: Hospitalization (all-cause): the subject is admitted to inpatient hospital care and discharged on a different calendar date. Heart Failure Hospitalization: the subject is admitted with signs/symptoms of congestive heart failure and receives unscheduled augmented Heart Failure therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy. Heart Failure Readmission (30-day): the subject is admitted for an unplanned hospitalization for any cause within 30 days post discharge from a Heart Failure hospitalization. Heart Failure Outpatient Visit: the subject has signs/symptoms of Congestive Heart Failure, and receives unscheduled intravenous decongestive therapy (e.g., Intravenous diuretics, Intravenous inotropes, Intravenous vasoactive drugs, ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency room, Heart Failure clinic, primary care clinic, etc.).
Tracking Information
- NCT #
- NCT03579641
- Collaborators
- Not Provided
- Investigators
- Study Director: Stephen Gaertner Boston Scientific Corporation