Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

NCT03579641 | Completed

• 1 other identifier: PREEMPT-HF
• Study Type: observational
• Target: 2,184
• Locations: 13 countries
• Sites: 88

Brief 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.

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; Latitude Remote Patient Monitor; Data Linkage; Sleep Incline Sensor; Respiratory Sensor; Decongestive Intravenous therapy; Decompensation

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Study Arms (1)

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

Device: HeartLogic Sensors

Interventions

HeartLogic Sensors DEVICE

HeartLogic Sensors

Implantable Cardiac device with HeartLogic feature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Heart Failure implanted with Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator using HeartLogic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (88)

Baptist Medical Center Princeton

Birmingham, Alabama, 35211, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, 72401, United States

Location

Baptist Health Medical Center (Little Rock)

Little Rock, Arkansas, 72205, United States

Location

Providence St. Joseph Medical Center

Burbank, California, 91505, United States

Location

Mission Hospital

Mission Viejo, California, 92691, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90503, United States

Location

Cardiology Physicians, PA

Newark, Delaware, 19713, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Watson Clinic Center for Research, Inc.

Lakeland, Florida, 33805, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Florida Hospital

Winter Park, Florida, 32792, United States

Location

CorVita Science Foundation (NFP)

Chicago, Illinois, 60605, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Mass Heart and Rhythm

Leominster, Massachusetts, 01453, United States

Location

Advanced Cardiovascular Clinic

Flint, Michigan, 48532, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Luke's Hospital-Duluth

Duluth, Minnesota, 55805, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Hattiesburg Clinic, P.A.

Hattiesburg, Mississippi, 39401, United States

Location

Heart and Vascular Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

St. Joseph Mercy Hospital Oakland

Pontiac, Missouri, 48341, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110-1093, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Capital Cardiology Associates

Albany, New York, 12211, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Strong Memorial Hospital of the University of Rochester

Rochester, New York, 14642, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Southern Oregon Cardiology, LLC

Medford, Oregon, 97504, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Francis Health System - St. Francis Hospital

Greenville, South Carolina, 29607, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

The University of Texas, Southwestern Medical Center

Dallas, Texas, 75390-8837, United States

Location

Orion Medical

Pasadena, Texas, 77505, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Riverside Regional Medical Center

Newport News, Virginia, 23601, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

Prince Charles Hospital

Chermside, Australia

Location

OLVZ Aalst

Aalst, Belgium

Location

CHUM

Montreal, Canada

Location

IUCPQ

Ste-Foy, Canada

Location

Aarhus University Hospital

Aarhus, Denmark

Location

CHU de Caen

Caen, France

Location

CHU de Nantes - Hôpital Laennec

Nantes, France

Location

APHP - Hospital de la Pitie-Salpetriere

Paris, France

Location

CHU de St. Etienne

Saint-Priest-en-Jarez, France

Location

Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie

Bochum, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Grantham Hospital

Aberdeen, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

University Hospital Waterford

Waterford, Ireland

Location

Az. Osp. G. Ciaccio Pontepiccolo

Catanzaro, Italy

Location

Az. Osp. Monaldi

Naples, Italy

Location

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Location

Azienda Osp Univ Integrata di Verona

Verona, Italy

Location

AMC

Amsterdam, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Universitair Medisch Centrum

Utrecht, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital de Gran Canaria Dr. Negrin

Las Palmas, Spain

Location

Hospital Universitario Virgen De La Victoria

Málaga, Spain

Location

Belfast City Hospital

Belfast, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

South Manchester University Hospital Trust

Manchester, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

New Cross Hospital

Wolverhampton, United Kingdom

Location

Related Publications (9)

• 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. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Ambrosy 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.

  PMID: 24491689 BACKGROUND

• Gheorghiade 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.

  PMID: 19215829 BACKGROUND

• Boehmer 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.

  PMID: 28254128 BACKGROUND

• Whellan 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.

  PMID: 28254129 BACKGROUND

• Desai 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.

  PMID: 22811548 BACKGROUND

• Dharmarajan 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.

  PMID: 28719692 BACKGROUND

• Shah 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.

  PMID: 25398313 BACKGROUND

• Sauer 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.

  PMID: 40272337 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Heart Diseases; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Gaertner

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 6, 2018
• Study Start: June 1, 2018
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

DK (1); BE (1); IE (1); NL (3); US (56); AU (1); HK (3); FR (4); IT (4); GB (7); DE (2); ES (3); CA (2)