Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices (MultiSENSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01128166
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : October 21, 2015
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Heart Failure Device: COGNIS CRT-D

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 975 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients
Study Start Date : June 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients implanted with a CRT-D (Cardiac Resynch. Therapy) Device: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Heart Failure (HF) events [ Time Frame: 12 Months ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with CRT-D devices(Heart Failure patients)
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128166


Locations
Show Show 99 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: John P Boehmer, M.D. Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01128166    
Other Study ID Numbers: MultiSENSE
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Keywords provided by Boston Scientific Corporation:
Heart Failure
Decompensation
Cardiac Resynchronization Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases