Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices
NCT ID: NCT01128166
Last Updated: 2015-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
975 participants
OBSERVATIONAL
2010-06-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients implanted with a CRT-D (Cardiac Resynch. Therapy)
COGNIS CRT-D
Patients with existing or newly implanted COGNIS® CRT-D pulse generators (PG)are enrolled in the study. PG is modified by the download of investigational software called Sensor Research Device-1™ (SRD-1). The goal of the SRD-1 system is to collect sensor data without affecting the delivered CRT-D therapy. This is accomplished through the "conversion" of an implanted COGNIS PG into a SRD-1 PG by downloading investigational software. Only a market approved COGNIS model N119/N120/P107/P108 device may be converted to a SRD-1 investigational device. There will be no PG hardware changes resulting from the conversion.
Interventions
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COGNIS CRT-D
Patients with existing or newly implanted COGNIS® CRT-D pulse generators (PG)are enrolled in the study. PG is modified by the download of investigational software called Sensor Research Device-1™ (SRD-1). The goal of the SRD-1 system is to collect sensor data without affecting the delivered CRT-D therapy. This is accomplished through the "conversion" of an implanted COGNIS PG into a SRD-1 PG by downloading investigational software. Only a market approved COGNIS model N119/N120/P107/P108 device may be converted to a SRD-1 investigational device. There will be no PG hardware changes resulting from the conversion.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John P Boehmer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
Arizona Advanced Arrhythmias
Gilbert, Arizona, United States
Baptist Health Medical Center
Little Rock, Arizona, United States
Tri-City Cardiology
Mesa, Arizona, United States
Cardiovascular Consultants, LTD
Phoenix, Arizona, United States
Pima Heart Physicians, PC
Tucson, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States
LAC & USC Medical Center
Los Angeles, California, United States
John Muir Medical Center
Oakland, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Daytona Heart Group
Daytona Beach, Florida, United States
First Coast Cardiovascular
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Orlando Heart Center
Orlando, Florida, United States
Winter Haven Hospital
Winter Haven, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
St Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
Wellstar Research Institute
Marietta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
St. Mary's Medical Center
Evansville, Indiana, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States
Parkview Hospital, Inc.
Fort Wayne, Indiana, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
La Porte Hospital
La Porte, Indiana, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Genesis Medical Center
Davenport, Iowa, United States
Central Baptist Hospital
Lexington, Kentucky, United States
St. Joseph Hospital
Lexington, Kentucky, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
St Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Univeristy of MN Medical Center
Minneapolis, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
Bergan Cardiology -Alegent Bergan Mercy Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
New Jersey Cardiology Associates
West Orange, New Jersey, United States
Buffalo Cardiology and Pulmonary
Williamsville, New Jersey, United States
New York Methodist Hospital
Brooklyn, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Sanger Heart and Vascular Institution
Charlotte, North Carolina, United States
Cardiovascular Research Institute LLC
Canton, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
St. Elizabeth Health Center
Poland, Ohio, United States
Northwest Ohio Cardiology
Toledo, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Rogue Valley Medical Center
Medford, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
The Arrhythmia Institute
Newton, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Cardiovascular Associates of Rhode Island
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Stern Cardiovascular Foundation, Inc.
Memphis, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
South East Texas Clinical Research
Beaumont, Texas, United States
EP Heart
Houston, Texas, United States
Heart Hospital of Austin
Houston, Texas, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
University of VA Medical Center
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virgina Commonwealth University Hospital System
Richmond, Virginia, United States
Chippenham Medical Center
Richmond, Virginia, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Faculty Hospital U sv Anny
Brno, , Czechia
University Hospital Jena Cardiology
Jena, , Germany
Prince of Wales Hospital
Shatin, Hong Kong, Hong Kong
Hungarian Institute of Cardiology
Budapest, , Hungary
Semmelweis University, Cardiovascular Center
Budapest, , Hungary
Allami Egeszsegugyi Kozpont (AEK) Hospital
Budapest, , Hungary
Kaplan Medical Centre
Rehovot, , Israel
Az. Osp. Lancisi
Ancona, , Italy
Ospedale Sacro Cuore Don Calabria
Negrar, , Italy
Institut Jantung Negara
Kuala Lumpur, , Malaysia
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum
Utrecht, , Netherlands
The National Institute of Cardiovascular Diseases - NUSCH
Bratislava, , Slovakia
VUSCH a.s.
Košice, , Slovakia
Ramathibodi Hospital
Bangkok, , Thailand
Her Majesty Cardiac Center, Siriraj Hospital
Bangkok, , Thailand
Golden Jubilee National Hospital
Clydebank, , United Kingdom
The Heart Hospital
London, , United Kingdom
Countries
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References
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
Other Identifiers
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MultiSENSE
Identifier Type: -
Identifier Source: org_study_id
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