Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-26 @ 8:44 AM
Study NCT ID:
NCT01128166
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 975}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-20', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Failure (HF) events', 'timeFrame': '12 Months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Decompensation', 'Cardiac Resynchronization Therapy'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'pmid': '35210075', 'type': 'DERIVED', '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.'}, {'pmid': '33619893', 'type': 'DERIVED', '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.'}, {'pmid': '30002113', 'type': 'DERIVED', '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.'}, {'pmid': '28254128', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with CRT-D devices(Heart Failure patients)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or above, or of legal age to give informed consent specific to state and national law\n* Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate\n* Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center\n* Currently implanted with a COGNIS device (Model N119 or N120, P107, P108)\n* Classified as NYHA Class II, III or IV within the last six months\n\nExclusion Criteria:\n\n* Inability or refusal to sign the Subject Informed Consent\n* Inability of refusal to comply with the follow-up schedule\n* Documented as pacemaker dependent\n* Unable to rest comfortably in a semi-recumbent position for up to 20 minutes\n* Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949\n* Currently implanted with unipolar RA, RV, or LV leads\n* LV sensitivity programmed to less than 0.7 mV AGC\n* History of appropriate tachycardia therapy (external or implanted) for rates \\< 165 bpm within 1 week prior to enrollment\n* Device battery status indicates approximate time to explant \\< 2 years\n* Likely to undergo lead or PG revision during the course of the study as determined by the investigator\n* Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen\n* Have received heart or lung transplant\n* Receiving mechanical circulatory support\n* Patients who have been referred or admitted for Hospice care\n* A life expectancy of less than 12 months per physician discretion\n* Enrolled in any concurrent study without Boston Scientific written approval\n* Devices previously converted to the SRD-1 and withdrawn from the study\n* Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol\n* Known pregnancy or plan to become pregnant within the course of the study\n* LV offset is programmed to a value greater than zero'}, 'identificationModule': {'nctId': 'NCT01128166', 'acronym': 'MultiSENSE', 'briefTitle': 'Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients', 'orgStudyIdInfo': {'id': 'MultiSENSE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients implanted with a CRT-D (Cardiac Resynch. Therapy)', 'interventionNames': ['Device: COGNIS CRT-D']}], 'interventions': [{'name': 'COGNIS CRT-D', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Patients implanted with a CRT-D (Cardiac Resynch. Therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Advanced Arrhythmias', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '77205', 'city': 'Little Rock', 'state': 'Arizona', 'country': 'United States', 'facility': 'Baptist Health Medical Center'}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tri-City Cardiology', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Consultants, LTD', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 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