Clinical trial NCT01128166: Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices
Official title: Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Decompensation
Cardiac Resynchronization Therapy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Milton S. Hershey Medical Center
First posted: 2010-05-21
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with CRT-D devices(Heart Failure patients)

Brief summary: The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

Detailed description: The purpose of MultiSENSE study is to collect data about patient events during worsening heart failure, determine how sensor measurements vary during patient daily activities and during the development and recovery from events of worsening heart failure, develop algorithms capable of detecting the onset of worsening heart failure prior to the overt presentation of patient symptoms using reference measurements: thoracic impedance, heart sounds, physiologic responses to activities and respiration.

Eligibility criteria: Inclusion Criteria:

* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate
* Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center
* Currently implanted with a COGNIS device (Model N119 or N120, P107, P108)
* Classified as NYHA Class II, III or IV within the last six months

Exclusion Criteria:

* Inability or refusal to sign the Subject Informed Consent
* Inability of refusal to comply with the follow-up schedule
* Documented as pacemaker dependent
* Unable to rest comfortably in a semi-recumbent position for up to 20 minutes
* Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949
* Currently implanted with unipolar RA, RV, or LV leads
* LV sensitivity programmed to less than 0.7 mV AGC
* History of appropriate tachycardia therapy (external or implanted) for rates \< 165 bpm within 1 week prior to enrollment
* Device battery status indicates approximate time to explant \< 2 years
* Likely to undergo lead or PG revision during the course of the study as determined by the investigator
* Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen
* Have received heart or lung transplant
* Receiving mechanical circulatory support
* Patients who have been referred or admitted for Hospice care
* A life expectancy of less than 12 months per physician discretion
* Enrolled in any concurrent study without Boston Scientific written approval
* Devices previously converted to the SRD-1 and withdrawn from the study
* Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol
* Known pregnancy or plan to become pregnant within the course of the study
* LV offset is programmed to a value greater than zero

Primary outcomes:
measure: Heart Failure (HF) events
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Gilbert
country: United States
facility: Arizona Advanced Arrhythmias
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arizona
city: Mesa
country: United States
facility: Tri-City Cardiology
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Consultants, LTD
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians, PC
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: LAC & USC Medical Center
state: California
city: Oakland
country: United States
facility: John Muir Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Daytona Heart Group
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Heart Center
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: St Joseph's Hospital of Atlanta
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Research Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Evansville
country: United States
facility: St. Mary's Medical Center
state: Indiana
city: Ft. Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Ft. Wayne
country: United States
facility: Parkview Hospital, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: La Porte
country: United States
facility: La Porte Hospital
state: Indiana
city: Cedar Rapids
country: United States
facility: St. Luke's Hospital
state: Iowa
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St Joseph Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Univeristy of MN Medical Center
state: Minnesota
city: St. Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Omaha
country: United States
facility: Bergan Cardiology -Alegent Bergan Mercy Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: West Orange
country: United States
facility: New Jersey Cardiology Associates
state: New Jersey
city: Williamsville
country: United States
facility: Buffalo Cardiology and Pulmonary
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital of the University of Rochester
state: New York
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institution
state: North Carolina
city: Canton
country: United States
facility: Cardiovascular Research Institute LLC
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Poland
country: United States
facility: St. Elizabeth Health Center
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Medford
country: United States
facility: Rogue Valley Medical Center
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Newton
country: United States
facility: The Arrhythmia Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Cardiovascular Associates of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Stern Cardiovascular Foundation, Inc.
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Beaumont
country: United States
facility: South East Texas Clinical Research
state: Texas
city: Houston
country: United States
facility: EP Heart
state: Texas
city: Houston
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Charlottesville
country: United States
facility: University of VA Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virgina Commonwealth University Hospital System
state: Virginia
city: Richmond
country: United States
facility: Chippenham Medical Center
state: Virginia
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
city: Brno
country: Czech Republic
facility: Faculty Hospital U sv Anny
city: Jena
country: Germany
facility: University Hospital Jena Cardiology
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Hungarian Institute of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis University, Cardiovascular Center
city: Budapest
country: Hungary
facility: Allami Egeszsegugyi Kozpont (AEK) Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Centre
city: Ancona
country: Italy
facility: Az. Osp. Lancisi
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum
city: Bratislava
country: Slovakia
facility: The National Institute of Cardiovascular Diseases - NUSCH
city: Kosice
country: Slovakia
facility: VUSCH a.s.
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Her Majesty Cardiac Center, Siriraj Hospital
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: The Heart Hospital
Study officials:
affiliation: Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
name: John P Boehmer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: J. P. Boehmer, Q. An, Y. Zhang, A. Shih, Variation in daily median respiratory rate identifies patients at higher risk of worsening HF in 30 days, Heart Rhythm, 2013;10(5):S66
citation: J. P. Boehmer, Q. An, Y. Zhang, A. Shih, Patients with higher standard deviation in daily median respiratory rate are at higher risk of worsening HF in 30 days, Europace, 2013;15(Suppl 2):ii96
citation: J. P. Boehmer, Y. Zhang, K. C. Beck, R. J. Sweeny, Physiologic sensor response to activity level in the MultiSENSE Study, European Journal of Heart Failure, 2013:12 (suppl 1), S194-5
citation: J. Hatlestad, S. Mehta, J. Whelan-Schwartz, R. Shankar and J.P. Boehmer, M.D..Night-time Elevation Angles In MultiSENSE Study Are Related To Symptoms of Orthopnea & Paroxysmal Nocturnal Dyspnea, Journal of Cardiac Failure, Vol. 18 No. 8S, Aug 2012, pp. S8
citation: J. P. Boehmer, V. Averina, P. Thakur, Y. Zhang, R. J. Sweeny, J. Thompson, Device-based sensors in the MultiSENSE Study: a preliminary view, Journal of Cardiac Failure, Vol. 18 No. 8S, Aug 2012, pp. S18
citation: J. P. Boehmer, Y. Zhang, R. J. Sweeny, R. Wariar, Q. An, P. Thakur, V. Averina, J. Thompson, Quantifying circadian variation of multiple physiologic signals in ambulatory heart failure patients, Journal of Cardiac Failure, Vol. 18 No. 8S, Aug 2012, pp. S90
citation: J. P. Boehmer, Y. Zhang, K. C. Beck, R. J. Sweeny, Physiologic sensor response to activity level in the MultiSENSE Study, Journal of Cardiac Failure, Vol. 17 No. 8S, Aug 2011, pp. S105
citation: J. P. Boehmer, Y. Zhang, R. J. Sweeny, R. Wariar, Q. An, P. Thakur, V. Averina, J. Thompson, Quantifying circadian variation of multiple physiologic signals in ambulatory heart failure patients, European Heart Journal, Vol. 33 Suppl 1, Aug 2012, pp. 162
citation: G. Molon, A. Capucci, Y. Zhang, Nicholas Wold, Qi An, Scott Wehrenberg, Existing device diagnostics identify patients at higher risk of worsening heart failure in 30 days, Europace, 2014; 16(Suppl 2):ii123
citation: J. Boehmer, Q. An, Y. Zhang, Variation in daily median respiratory rate identifies patients at higher risk of worsening HF in 30 days, Heart & Lung: The Journal of Acute and Critical Care, July 2014; 43(4), pp. 381
citation: Michael Cao, Michael Gold, Yi Zhang, Nicholas Wold, Scott Wehrenberg, Qi An, John Boehmer , Implantable device diagnostics identify patients at higher risk of heart failure events in 30 days, Heart & Lung: The Journal of Acute and Critical Care, July 2014; 43(4), pp. 381-2
citation: A. Capucci, G. Molon, M R. Gold, Y. Zhang, R. Sweeney, V. Averina, J P. Boehmer, Rapid shallow breathing worsens prior to heart failure decompensation, European Heart Journal, Vol. 35, Suppl 1, Sept. 2014, pp. 678
citation: Alessandro Capucci, Giulio Molon, Michael R. Gold, Yi Zhang, Robert Sweeney, Viktoria Averina, John P. Boehmer, Rapid Shallow Breathing Worsens Prior to Heart Failure Decompensation, Journal of Cardiac Failure, Aug. 2014; 20 (8), S14
citation: Devi Nair, Roy Gardner, Roy Small, Ramesh Hariharan, Qi An, Pramodsingh H. Thakur, John Boehmer, Baseline S3 Measured using Implanted Accelerometer is more Prominent in Patients with Heart Failure Decompensations, Heart Rhythm, 2015;12(5):S419-420, PO05-45
citation: Capucci A, Wong JA, Gold MR, Boehmer J, Ahmed R, Kwan B, Thakur PH, Zhang Y, Jones PW, Healey JS. Temporal Association of Atrial Fibrillation With Cardiac Implanted Electronic Device Detected Heart Failure Status. JACC Clin Electrophysiol. 2022 Feb;8(2):182-193. doi: 10.1016/j.jacep.2021.09.015. Epub 2021 Nov 24.
citation: Gardner RS, Thakur P, Hammill EF, Nair DG, Eldadah Z, Stancak B, Ferrick K, Sriratanasathavorn C, Duray GZ, Wariar R, Zhang Y, An Q, Averina V, Boehmer JP. Multiparameter diagnostic sensor measurements during clinically stable periods and worsening heart failure in ambulatory patients. ESC Heart Fail. 2021 Apr;8(2):1571-1581. doi: 10.1002/ehf2.13261. Epub 2021 Feb 22.
citation: Gardner RS, Singh JP, Stancak B, Nair DG, Cao M, Schulze C, Thakur PH, An Q, Wehrenberg S, Hammill EF, Zhang Y, Boehmer JP. HeartLogic Multisensor Algorithm Identifies Patients During Periods of Significantly Increased Risk of Heart Failure Events: Results From the MultiSENSE Study. Circ Heart Fail. 2018 Jul;11(7):e004669. doi: 10.1161/CIRCHEARTFAILURE.117.004669.
citation: 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.