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NCT03579641 · ClinicalTrials.gov registry record
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 2,184
- Enrollment target
NCT03579641: Completed study, sponsored by Boston Scientific Corporation.
NCT03579641 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 2,184 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03579641 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 2,184 participants
- Enrollment target
Study Summary
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.
Primary Outcome
To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.
Interventions
- DEVICE HeartLogic Sensors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,184 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2021-10-29 |
What the finished NCT03579641 record still lists
NCT03579641 is an observational study that tracks outcomes without assigning an intervention. Its 2,184 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which HeartLogic Sensors is the first listed.
NCT03579641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03579641 about?
NCT03579641 is a clinical study titled "Precision Event Monitoring for Patients With Heart Failure Using HeartLogic". The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy de...
What is the current status of trial NCT03579641?
This trial is currently completed. The enrollment target is 2,184 participants. The study started on 2018-06-01. Estimated completion is 2021-10-29.
What interventions are being tested in trial NCT03579641?
The interventions under investigation include: HeartLogic Sensors (DEVICE).
Who is sponsoring clinical trial NCT03579641?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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