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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01128166
First received: May 20, 2010
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention
Heart Failure
Device: COGNIS CRT-D

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Heart Failure (HF) events [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 975
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128166

  Show 99 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Milton S. Hershey Medical Center
Investigators
Principal Investigator: John P Boehmer, M.D. Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01128166     History of Changes
Other Study ID Numbers: MultiSENSE
Study First Received: May 20, 2010
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Heart Failure
Decompensation
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014