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Heart FailureMultiSENSENCT01128166

Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

An observational study of Heart Failure, run by Boston Scientific Corporation at 99 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
COGNIS CRT-D
Type of treatment
Medical device
How many people
975 participants
Where
99 sitesin 12 countries
Study dates
Jun 2010to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

99 sites in 12 countries.

99 sites in 12 countries

United States81 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • St Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • St Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705

  • South East Texas Clinical Research

    Beaumont, Texas, 77702

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Cardiovascular Research Institute LLC

    Canton, Ohio, 44708

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52043

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Sanger Heart and Vascular Institution

    Charlotte, North Carolina, 28203

  • University of VA Medical Center

    Charlottesville, Virginia, 2911

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Ohio Health Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohio, 43215

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Daytona Heart Group

    Daytona Beach, Florida, 32114

  • St. Mary's Medical Center

    Evansville, Indiana, 47750

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana, 46804

  • Parkview Hospital, Inc.

    Fort Wayne, Indiana, 46845

  • Northeast Georgia Heart Center

    Gainesville, Georgia, 30501

  • Arizona Advanced Arrhythmias

    Gilbert, Arizona, 85297

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1963

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • EP Heart

    Houston, Texas, 77030

  • Heart Hospital of Austin

    Houston, Texas, 78756

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46260

  • First Coast Cardiovascular

    Jacksonville, Florida, 32216

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas, 72401

  • La Porte Hospital

    La Porte, Indiana, 46250

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • St. Joseph Hospital

    Lexington, Kentucky, 40504

  • Baptist Health Medical Center

    Little Rock, Arizona, 77205

  • LAC & USC Medical Center

    Los Angeles, California, 90033

  • Wellstar Research Institute

    Marietta, Georgia, 30060

  • Rogue Valley Medical Center

    Medford, Oregon, 26341

  • Stern Cardiovascular Foundation, Inc.

    Memphis, Tennessee, 38120

  • Tri-City Cardiology

    Mesa, Arizona, 85206

  • Univeristy of MN Medical Center

    Minneapolis, Minnesota, 55455

  • Monongalia General Hospital

    Morgantown, West Virginia, 26505

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • The Arrhythmia Institute

    Newton, Pennsylvania, 18940

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • John Muir Medical Center

    Oakland, California, 94609-3102

  • Bergan Cardiology -Alegent Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Orlando Heart Center

    Orlando, Florida, 32806

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Cardiovascular Consultants, LTD

    Phoenix, Arizona, 85032

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • St. Elizabeth Health Center

    Poland, Ohio, 44514

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Cardiovascular Associates of Rhode Island

    Providence, Rhode Island, 02904

  • Virgina Commonwealth University Hospital System

    Richmond, Virginia, 23219

  • Chippenham Medical Center

    Richmond, Virginia, 23225

  • Strong Memorial Hospital of the University of Rochester

    Rochester, New York, 14642

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • University of Utah Hospital and Clinics

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Cardiovascular Associates of the Delaware Valley

    Sewell, New Jersey, 08080

  • Providence Hospital

    Southfield, Michigan, 48075

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Northwest Ohio Cardiology

    Toledo, Ohio, 43615

  • Pima Heart Physicians, PC

    Tucson, Arizona, 85712

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010-2975

  • New Jersey Cardiology Associates

    West Orange, New Jersey, 07052

  • Buffalo Cardiology and Pulmonary

    Williamsville, New Jersey, 14221-5538

  • Winter Haven Hospital

    Winter Haven, Florida, 33881

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067

Other trials in United States

Hungary3 sites

  • Hungarian Institute of Cardiology

    Budapest, 1096

  • Semmelweis University, Cardiovascular Center

    Budapest, 1122

  • Allami Egeszsegugyi Kozpont (AEK) Hospital

    Budapest, 1134

Other trials in Hungary

Italy2 sites

  • Az. Osp. Lancisi

    Ancona, 60100

  • Ospedale Sacro Cuore Don Calabria

    Negrar, 37024

Other trials in Italy

Netherlands2 sites

  • Leiden University Medical Center

    Leiden, 2333 ZA

  • Universitair Medisch Centrum

    Utrecht, 3584 CX

Other trials in Netherlands

Slovakia2 sites

  • The National Institute of Cardiovascular Diseases - NUSCH

    Bratislava, 83348

  • VUSCH a.s.

    Košice, 04011

Other trials in Slovakia

Thailand2 sites

  • Ramathibodi Hospital

    Bangkok, 10400

  • Her Majesty Cardiac Center, Siriraj Hospital

    Bangkok

Other trials in Thailand

United Kingdom2 sites

  • Golden Jubilee National Hospital

    Clydebank, G81 4HX

  • The Heart Hospital

    London, W1G 8PH

Other trials in United Kingdom

Czechia1 site

  • Faculty Hospital U sv Anny

    Brno, 65691

Other trials in Czechia

Germany1 site

  • University Hospital Jena Cardiology

    Jena, 07747

Other trials in Germany

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin, Hong Kong, 999077

Other trials in Hong Kong

Israel1 site

  • Kaplan Medical Centre

    Rehovot, 76100

Other trials in Israel

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur, 50400

Other trials in Malaysia

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
COGNIS CRT-D
Keywords
Heart Failure, Decompensation, Cardiac Resynchronization Therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COGNIS CRT-DDevice

    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.

Study groups in NCT01128166
Study groupRoleWhat they receive
Patients implanted with a CRT-D (Cardiac Resynch. Therapy)Not described
Receives: Device: COGNIS CRT-D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
975 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01128166
Sponsor's protocol ID
MultiSENSE
Acronym
MultiSENSE
Status last verified
Oct 2015
First submitted
20 May 2010
Last updated
21 Oct 2015
Results posted
No
Data monitoring committee
Yes

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

  • 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.

    PubMed 35210075

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Boston Scientific Corporation at 99 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Hungary, Italy, Netherlands, Slovakia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Failure (HF) events (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01128166, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015; AzTrials last refreshed its copy on 27 Oct 2026.

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