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

October 19, 2015 updated by: Boston Scientific Corporation

Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients

The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
975

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 65691
        • Faculty Hospital U sv Anny
  • Germany
      • Jena, Germany, 07747
        • University Hospital Jena Cardiology
  • Hong Kong
      • Shatin, Hong Kong, 999077
        • Prince of Wales Hospital
  • Hungary
      • Budapest, Hungary, 1096
        • Hungarian Institute of Cardiology
      • Budapest, Hungary, 1122
        • Semmelweis University, Cardiovascular Center
      • Budapest, Hungary, 1134
        • Allami Egeszsegugyi Kozpont (AEK) Hospital
  • Israel
      • Rehovot, Israel, 76100
        • Kaplan Medical Centre
  • Italy
      • Ancona, Italy, 60100
        • Az. Osp. Lancisi
      • Negrar, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum
  • Slovakia
      • Bratislava, Slovakia, 83348
        • The National Institute of Cardiovascular Diseases - NUSCH
      • Kosice, Slovakia, 04011
        • VUSCH a.s.
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand
        • Her Majesty Cardiac Center, Siriraj Hospital
  • United Kingdom
      • Clydebank, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital
      • London, United Kingdom, W1G 8PH
        • The Heart Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Arizona Advanced Arrhythmias
      • Little Rock, Arizona, United States, 77205
        • Baptist Health Medical Center
      • Mesa, Arizona, United States, 85206
        • Tri-City Cardiology
      • Phoenix, Arizona, United States, 85032
        • Cardiovascular Consultants, Ltd
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
      • Tucson, Arizona, United States, 85712
        • Pima Heart Physicians, PC
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Cardiology Associates of Northeast Arkansas
    • California
      • Los Angeles, California, United States, 90033
        • LAC & USC Medical Center
      • Oakland, California, United States, 94609-3102
        • John Muir Medical Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Hartford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2975
        • Washington Hospital Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Daytona Heart Group
      • Jacksonville, Florida, United States, 32216
        • First Coast Cardiovascular
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Orlando Heart Center
      • Winter Haven, Florida, United States, 33881
        • Winter Haven Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30342
        • St Joseph's Hospital of Atlanta
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center
      • Marietta, Georgia, United States, 30060
        • Wellstar Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Indiana
      • Evansville, Indiana, United States, 47750
        • St. Mary's Medical Center
      • Ft. Wayne, Indiana, United States, 46804
        • Northern Indiana Research Alliance
      • Ft. Wayne, Indiana, United States, 46845
        • Parkview Hospital, Inc.
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent's Hospital
      • La Porte, Indiana, United States, 46250
        • La Porte Hospital
    • Iowa
      • Cedar Rapids, Iowa, United States, 52043
        • St. Luke's Hospital
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • St. Joseph Hospital
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St Joseph Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Michigan Cardiovascular Institute
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univeristy of MN Medical Center
      • St. Paul, Minnesota, United States, 55102
        • HealthEast St. Joseph's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Bergan Cardiology -Alegent Bergan Mercy Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-1963
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
      • Sewell, New Jersey, United States, 08080
        • Cardiovascular Associates of the Delaware Valley
      • West Orange, New Jersey, United States, 07052
        • New Jersey Cardiology Associates
      • Williamsville, New Jersey, United States, 14221-5538
        • Buffalo Cardiology and Pulmonary
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital of the University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Heart and Vascular Institution
    • Ohio
      • Canton, Ohio, United States, 44708
        • Cardiovascular Research Institute LLC
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Columbus, Ohio, United States, 43215
        • Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
      • Poland, Ohio, United States, 44514
        • St. Elizabeth Health Center
      • Toledo, Ohio, United States, 43615
        • Northwest Ohio Cardiology
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute
    • Oregon
      • Medford, Oregon, United States, 26341
        • Rogue Valley Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Newton, Pennsylvania, United States, 18940
        • The Arrhythmia Institute
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02904
        • Cardiovascular Associates of Rhode Island
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Stern Cardiovascular Foundation, Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research
      • Beaumont, Texas, United States, 77702
        • South East Texas Clinical Research
      • Houston, Texas, United States, 77030
        • EP Heart
      • Houston, Texas, United States, 78756
        • Heart Hospital of Austin
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Hospital and Clinics
    • Virginia
      • Charlottesville, Virginia, United States, 2911
        • University of VA Medical Center
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23225
        • Chippenham Medical Center
      • Richmond, Virginia, United States, 23219
        • Virgina Commonwealth University Hospital System
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Monongalia General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with CRT-D devices(Heart Failure patients)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Milton S. Hershey Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John P Boehmer, M.D., Milton S Hershey Medical Center, Hershey, Pennsylvania, United States

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MultiSENSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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