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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
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The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted with a CRT-D (Cardiac Resynch. Therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COGNIS CRT-D | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure (HF) events | The primary objectives of this study are to determine how ambulatory sensor measurements change with worsening heart failure, and to develop multisensor detection algorithms. Additional data will be collected to compare sensor measurements against reference measurements when the subject is hospitalized for HF. Data from this study may also be used for determining prospective endpoints and sample sizes for future studies. There are no formal statistical primary or secondary endpoints defined for this study. Therefore, no formal tests of hypothesis will be conducted. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with CRT-D devices(Heart Failure patients)
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| Name | Affiliation | Role |
|---|---|---|
| John P Boehmer, M.D. | Milton S Hershey Medical Center, Hershey, Pennsylvania, United States | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States | ||
| Arizona Advanced Arrhythmias |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 |
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|
| Gilbert |
| Arizona |
| 85297 |
| United States |
| Baptist Health Medical Center | Little Rock | Arizona | 77205 | United States |
| Tri-City Cardiology | Mesa | Arizona | 85206 | United States |
| Cardiovascular Consultants, LTD | Phoenix | Arizona | 85032 | United States |
| Pima Heart Physicians, PC | Tucson | Arizona | 85712 | United States |
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | United States |
| Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | 72401 | United States |
| LAC & USC Medical Center | Los Angeles | California | 90033 | United States |
| John Muir Medical Center | Oakland | California | 94609-3102 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102-5037 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010-2975 | United States |
| Daytona Heart Group | Daytona Beach | Florida | 32114 | United States |
| First Coast Cardiovascular | Jacksonville | Florida | 32216 | United States |
| Lakeland Regional Medical Center | Lakeland | Florida | 33805 | United States |
| Orlando Heart Center | Orlando | Florida | 32806 | United States |
| Winter Haven Hospital | Winter Haven | Florida | 33881 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| St Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342 | United States |
| Northeast Georgia Heart Center | Gainesville | Georgia | 30501 | United States |
| Wellstar Research Institute | Marietta | Georgia | 30060 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| St. Mary's Medical Center | Evansville | Indiana | 47750 | United States |
| Northern Indiana Research Alliance | Fort Wayne | Indiana | 46804 | United States |
| Parkview Hospital, Inc. | Fort Wayne | Indiana | 46845 | United States |
| St. Vincent's Hospital | Indianapolis | Indiana | 46260 | United States |
| La Porte Hospital | La Porte | Indiana | 46250 | United States |
| St. Luke's Hospital | Cedar Rapids | Iowa | 52043 | United States |
| Genesis Medical Center | Davenport | Iowa | 52803 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| St. Joseph Hospital | Lexington | Kentucky | 40504 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| St Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Michigan Cardiovascular Institute | Saginaw | Michigan | 48601 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Univeristy of MN Medical Center | Minneapolis | Minnesota | 55455 | United States |
| HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| Bergan Cardiology -Alegent Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601-1963 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey | 08080 | United States |
| New Jersey Cardiology Associates | West Orange | New Jersey | 07052 | United States |
| Buffalo Cardiology and Pulmonary | Williamsville | New Jersey | 14221-5538 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Strong Memorial Hospital of the University of Rochester | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Sanger Heart and Vascular Institution | Charlotte | North Carolina | 28203 | United States |
| Cardiovascular Research Institute LLC | Canton | Ohio | 44708 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Ohio Health Research and Innovation Institute - Riverside Methodist Hospital | Columbus | Ohio | 43215 | United States |
| St. Elizabeth Health Center | Poland | Ohio | 44514 | United States |
| Northwest Ohio Cardiology | Toledo | Ohio | 43615 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | United States |
| Rogue Valley Medical Center | Medford | Oregon | 26341 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| The Arrhythmia Institute | Newton | Pennsylvania | 18940 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Cardiovascular Associates of Rhode Island | Providence | Rhode Island | 02904 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Stern Cardiovascular Foundation, Inc. | Memphis | Tennessee | 38120 | United States |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | United States |
| South East Texas Clinical Research | Beaumont | Texas | 77702 | United States |
| EP Heart | Houston | Texas | 77030 | United States |
| Heart Hospital of Austin | Houston | Texas | 78756 | United States |
| University of Utah Hospital and Clinics | Salt Lake City | Utah | 84112 | United States |
| University of VA Medical Center | Charlottesville | Virginia | 2911 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Virgina Commonwealth University Hospital System | Richmond | Virginia | 23219 | United States |
| Chippenham Medical Center | Richmond | Virginia | 23225 | United States |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | United States |
| Faculty Hospital U sv Anny | Brno | 65691 | Czechia |
| University Hospital Jena Cardiology | Jena | 07747 | Germany |
| Prince of Wales Hospital | Shatin | Hong Kong | 999077 | Hong Kong |
| Hungarian Institute of Cardiology | Budapest | 1096 | Hungary |
| Semmelweis University, Cardiovascular Center | Budapest | 1122 | Hungary |
| Allami Egeszsegugyi Kozpont (AEK) Hospital | Budapest | 1134 | Hungary |
| Kaplan Medical Centre | Rehovot | 76100 | Israel |
| Az. Osp. Lancisi | Ancona | 60100 | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | 37024 | Italy |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Universitair Medisch Centrum | Utrecht | 3584 CX | Netherlands |
| The National Institute of Cardiovascular Diseases - NUSCH | Bratislava | 83348 | Slovakia |
| VUSCH a.s. | Košice | 04011 | Slovakia |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Her Majesty Cardiac Center, Siriraj Hospital | Bangkok | Thailand |
| Golden Jubilee National Hospital | Clydebank | G81 4HX | United Kingdom |
| The Heart Hospital | London | W1G 8PH | United Kingdom |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| 35210075 | Derived | 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. |
| 33619893 | Derived | 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. |
| 30002113 | Derived | 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. |
| 28254128 | Derived | 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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