The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure (HF) patients with an implantable…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective
The primary objective of the PREEMPT-HF study is to investigate the
association between HF sensor data and 30-day HF readmissions.
Secondary outcome
Additional Objectives
1. Characterize HF sensor data for:
o Association with risk for device VT/VF therapy
o Phenomapping of HF events
o Association with non-HF hospitalizations including cardiac non-HF
events and non-cardiac events
2. Collect subject Sleep Incline Sensor data prior to and following reviewable
clinical events
3. Link study data to third-party data, such as Center for Medicare and
Medicaid Services (CMS) administrative claims (US only). Association of
clinical study events and sensor data with other data sources will be
investigated. Any study data linkage will abide by all applicable laws,
regulations, and data use agreements, and patients will be consented
accordingly.
Background summary
Heart failure (HF) is a complex clinical syndrome with high morbidity,
mortality, and economic burden. Chronic HF 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 HF and prevent hospitalizations.
Study objective
The goal of the PREEMPT-HF study is to collect device and clinical event data
to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic
(HeartLogic) in a broad spectrum of heart failure (HF) patients with an
implantable cardioverter defibrillator (ICD) or cardiac resynchronization
therapy defibrillator (CRT-D). There are no primary safety and/or efficacy
endpoints for this study.
Study design
The PREEMPT-HF study is a global, multi-center, post-market prospective,
non-randomized study.
1. Subject Consent and Enrollment Visit (post implant)
2. Baseline Visit: (Must occur >=7 days post implant and <= 30 days post
enrollment)
3. Interim Medical Record Review: [NO subject visit required] 6 Month
4. Final Clinic Visit: 12 Month
5. Study exit
Study burden and risks
There are no required treatments or therapeutic interventions in this trial.
The study involves the collection of sensor data and clinical event data. There
are no additional risks of participating above those associated with standard
of care.
Please refer to the Directions for Use for an overview of anticipated adverse
(device) effects, and risks associated to the commercial device(s).
There may be no benefits to a subject*s participation in the study. However,
participation may help future patients benefit from enhanced performance of the
HeartLogic algorithm.
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67313.058.19 |