Heart FailurePREEMPT-HFNCT03579641
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
An observational study of Heart Failure and Defibrillators, Implantable, run by Boston Scientific Corporation at 88 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic
- What is being tested?
- HeartLogic Sensors
- Type of treatment
- Medical device
- How many people
- 2,184 participants
- Where
- 88 sitesin 13 countries
- Study dates
- 1 Jun 2018to 29 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Heart Failure implanted with Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator using HeartLogic
Who may be able to join
- 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 Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator 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 right ventricle 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.
Who cannot join
- 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
Trial locations and contacts
88 sites in 13 countries.
88 sites in 13 countries
United States56 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Albany Medical Center
Albany, New York, 12208
Capital Cardiology Associates
Albany, New York, 12211
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Seton Medical Center
Austin, Texas, 78705
University of Maryland Medical System
Baltimore, Maryland, 21201
Eastern Maine Medical Center
Bangor, Maine, 04401
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Medical Center
Boston, Massachusetts, 02118
Providence St. Joseph Medical Center
Burbank, California, 91505
Aultman Hospital
Canton, Ohio, 44710
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Erlanger Medical Center
Chattanooga, Tennessee, 37403
CorVita Science Foundation (NFP)
Chicago, Illinois, 60605
Rush University Medical Center
Chicago, Illinois, 60612
The University of Texas, Southwestern Medical Center
Dallas, Texas, 75390-8837
St. Luke's Hospital-Duluth
Duluth, Minnesota, 55805
Evanston Hospital
Evanston, Illinois, 60201
Providence Regional Medical Center Everett
Everett, Washington, 98201
Advanced Cardiovascular Clinic
Flint, Michigan, 48532
St. Francis Health System - St. Francis Hospital
Greenville, South Carolina, 29607
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, 39401
Heart and Vascular Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
St. Mary's Medical Center
Huntington, West Virginia, 25701
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Baptist Medical Center
Jacksonville, Florida, 32207
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
University of Kansas Hospital
Kansas City, Kansas, 66160
Watson Clinic Center for Research, Inc.
Lakeland, Florida, 33805
Mass Heart and Rhythm
Leominster, Massachusetts, 01453
Baptist Health Medical Center (Little Rock)
Little Rock, Arkansas, 72205
Southern Oregon Cardiology, LLC
Medford, Oregon, 97504
Mission Hospital
Mission Viejo, California, 92691
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802
Columbia University Medical Center
New York, New York, 10032
Cardiology Physicians, PA
Newark, Delaware, 19713
Riverside Regional Medical Center
Newport News, Virginia, 23601
Orion Medical
Pasadena, Texas, 77505
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
St. Joseph Mercy Hospital Oakland
Pontiac, Missouri, 48341
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Regions Hospital
Saint Paul, Minnesota, 55101
Sarasota Memorial Hospital
Sarasota, Florida, 34239
St. John's Hospital
Springfield, Illinois, 62701
Barnes Jewish Hospital
St Louis, Missouri, 63110-1093
Stanford University Medical Center
Stanford, California, 94305
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Harbor UCLA Medical Center
Torrance, California, 90502
Torrance Memorial Medical Center
Torrance, California, 90503
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701
Carle Foundation Hospital
Urbana, Illinois, 61801
Florida Hospital
Winter Park, Florida, 32792
United Kingdom7 sites
Belfast City Hospital
Belfast
Golden Jubilee National Hospital
Clydebank
Ninewells Hospital and Medical School
Dundee
Royal Infirmary of Edinburgh
Edinburgh
South Manchester University Hospital Trust
Manchester
Northern General Hospital
Sheffield
New Cross Hospital
Wolverhampton
France4 sites
CHU de Caen
Caen
CHU de Nantes - Hôpital Laennec
Nantes
APHP - Hospital de la Pitie-Salpetriere
Paris
CHU de St. Etienne
Saint-Priest-en-Jarez
Italy4 sites
Az. Osp. G. Ciaccio Pontepiccolo
Catanzaro
Az. Osp. Monaldi
Naples
Ospedale Sacro Cuore Don Calabria
Negrar
Azienda Osp Univ Integrata di Verona
Verona
Hong Kong3 sites
Grantham Hospital
Aberdeen
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Netherlands3 sites
AMC
Amsterdam
Leiden University Medical Center
Leiden
Universitair Medisch Centrum
Utrecht
Spain3 sites
Hospital Clinic de Barcelona
Barcelona
Hospital de Gran Canaria Dr. Negrin
Las Palmas
Hospital Universitario Virgen De La Victoria
Málaga
Germany2 sites
Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie
Bochum
Universitaetsklinikum Schleswig-Holstein
Lübeck
About this study
Official title: 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 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.
Read the detailed 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 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.).
- Conditions
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy, Cardiovascular Disease, Heart Disease
- Being tested
- HeartLogic Sensors
- Keywords
- Heart Failure, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Heart Failure Sensor Data, 30-day Heart Failure Readmission, Ventricular Tachycardia/Ventricular Fibrillation Therapy, Non-Heart Failure Hospitalization, HeartLogic Feature, Latitude Remote Patient Monitor, Data Linkage, Sleep Incline Sensor, Respiratory Sensor, Decongestive Intravenous therapy, Decompensation
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Diseases, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartLogic SensorsDevice
HeartLogic Sensors
| Study group | Role | What they receive |
|---|---|---|
| Implantable Cardiac device with HeartLogic feature | Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature Receives: Device: HeartLogic Sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of HeartLogic sensors with 30-day HF re-admission
To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.
Measured: Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jun 2018
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Gaertner, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579641
- Sponsor's protocol ID
- PREEMPT-HF
- Acronym
- PREEMPT-HF
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2018
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
PubMed 24491689Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.
PubMed 19215829Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.
PubMed 28254128Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006. No abstract available.
PubMed 28254129Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.
PubMed 22811548Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.
PubMed 28719692Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
PubMed 25398313Sauer AJ, Stolen CM, Shute JB, Kwan B, Wariar R, Ruble SB, Gardner RS, Boehmer JP. Results of the Precision Event Monitoring for Patients With Heart Failure Using HeartLogic Study (PREEMPT-HF). JACC Heart Fail. 2025 Jun;13(6):973-983. doi: 10.1016/j.jchf.2025.01.028. Epub 2025 Apr 23.
PubMed 40272337
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
- ClinicalTrials.gov ID
- NCT03579641
- Acronym / sponsor ID
- PREEMPT-HF / PREEMPT-HF
- Conditions
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy, Cardiovascular Disease, Heart Disease
- Keywords
- Heart Failure, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Heart Failure Sensor Data, 30-day Heart Failure Readmission, Ventricular Tachycardia/Ventricular Fibrillation Therapy, Non-Heart Failure Hospitalization, HeartLogic Feature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,184 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable Cardiac device with HeartLogic feature | – | Device: HeartLogic SensorsPatients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Heart Failure implanted with Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator using HeartLogic
Key inclusion criteria (5 listed)
- 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 Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator 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 right ventricle 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartLogic SensorsHeartLogic Sensors | Device | Implantable Cardiac device with HeartLogic feature |
Primary outcome
Association of HeartLogic sensors with 30-day HF re-admission
Time frame: Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial).
To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 24491689Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
- Background: PubMed 19215829Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.
- Background: PubMed 28254128Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.
- Background: PubMed 28254129Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006. No abstract available.
- Background: PubMed 22811548Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.
- Background: PubMed 28719692Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.
- Background: PubMed 25398313Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
- Derived from this study: PubMed 40272337Sauer AJ, Stolen CM, Shute JB, Kwan B, Wariar R, Ruble SB, Gardner RS, Boehmer JP. Results of the Precision Event Monitoring for Patients With Heart Failure Using HeartLogic Study (PREEMPT-HF). JACC Heart Fail. 2025 Jun;13(6):973-983. doi: 10.1016/j.jchf.2025.01.028. Epub 2025 Apr 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Gaertner study director
Boston Scientific Corporation
88 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Defibrillators, Implantable, run by Boston Scientific Corporation at 88 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, United Kingdom, France, Italy, Hong Kong and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of HeartLogic sensors with 30-day HF re-admission (time frame: Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579641, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.