Precision Event Monitoring for Patients With Heart Failure Using HeartLogic™
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | June 1, 2018 |
| End Date: | January 2026 |
| Contact: | Karen L Reidt, MBA |
| Email: | karen.reidt@bsci.com |
| Phone: | 651-202-8033 |
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic™ : PREEMPT-HF
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.
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. HeartLogicTM, available in
Boston Scientific cardiac resynchronization therapy devices and defibrillators (CRT-Ds and
ICDs), 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 HF. However, there is limited data on the association of
HeartLogic with the risk of HF readmissions and tachyarrhythmias, or for phenotyping the
broad spectrum of HF patients.
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.
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. HeartLogicTM, available in
Boston Scientific cardiac resynchronization therapy devices and defibrillators (CRT-Ds and
ICDs), 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 HF. However, there is limited data on the association of
HeartLogic with the risk of HF readmissions and tachyarrhythmias, or for phenotyping the
broad spectrum of HF patients.
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 (RCEs), and include all-cause hospitalizations and HF 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.
- HF Hospitalization: the subject is admitted with signs/symptoms of congestive heart
failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous
medications, ultrafiltration therapy or other parenteral therapy.
- HF Readmission (30-day): the subject is admitted for an unplanned hospitalization for
any cause within 30 days post discharge from a HF hospitalization.
- HF Outpatient Visit: the subject has signs/symptoms of CHF, and receives unscheduled
intravenous decongestive therapy (e.g., IV diuretics, IV inotropes, IV vasoactive drugs,
ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency
room, HF clinic, primary care clinic, etc.).
required number of clinical events to support the study objectives. These events are called
Reviewable Clinical Events (RCEs), and include all-cause hospitalizations and HF 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.
- HF Hospitalization: the subject is admitted with signs/symptoms of congestive heart
failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous
medications, ultrafiltration therapy or other parenteral therapy.
- HF Readmission (30-day): the subject is admitted for an unplanned hospitalization for
any cause within 30 days post discharge from a HF hospitalization.
- HF Outpatient Visit: the subject has signs/symptoms of CHF, and receives unscheduled
intravenous decongestive therapy (e.g., IV diuretics, IV inotropes, IV vasoactive drugs,
ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency
room, HF clinic, primary care clinic, etc.).
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
We found this trial at
6
sites
Newark, Delaware 19713
Principal Investigator: Brian H Sarter, MD
Phone: 302-999-0507
Click here to add this to my saved trials
Albany, New York 12208
Principal Investigator: Rizwan Alimohammad, MD
Phone: 518-292-6077
Click here to add this to my saved trials
Chicago, Illinois 60605
Principal Investigator: Martin C Burke
Phone: 773-432-4888
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
Principal Investigator: Randel L Smith, MD
Phone: 601-268-5794
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials