Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

Heart Failure Clinical Trial

— MultiSENSE  

Official title:

Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128166
• Other study ID #: MultiSENSE
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: October 19, 2015
• Start date: June 2010
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 975
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	Faculty Hospital U sv Anny	Brno
Germany	University Hospital Jena Cardiology	Jena
Hong Kong	Prince of Wales Hospital	Shatin
Hungary	Allami Egeszsegugyi Kozpont (AEK) Hospital	Budapest
Hungary	Hungarian Institute of Cardiology	Budapest
Hungary	Semmelweis University, Cardiovascular Center	Budapest
Israel	Kaplan Medical Centre	Rehovot
Italy	Az. Osp. Lancisi	Ancona
Italy	Ospedale Sacro Cuore Don Calabria	Negrar
Malaysia	Institut Jantung Negara	Kuala Lumpur
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Universitair Medisch Centrum	Utrecht
Slovakia	The National Institute of Cardiovascular Diseases - NUSCH	Bratislava
Slovakia	VUSCH a.s.	Kosice
Thailand	Her Majesty Cardiac Center, Siriraj Hospital	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	The Heart Hospital	London
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	St Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	St Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	South East Texas Clinical Research	Beaumont	Texas
United States	Montefiore Medical Center	Bronx	New York
United States	New York Methodist Hospital	Brooklyn	New York
United States	Cardiovascular Research Institute LLC	Canton	Ohio
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Sanger Heart and Vascular Institution	Charlotte	North Carolina
United States	University of VA Medical Center	Charlottesville	Virginia
United States	University of Chicago Hospital	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	The Christ Hospital	Cincinnati	Ohio
United States	Ohio Health Research and Innovation Institute - Riverside Methodist Hospital	Columbus	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Genesis Medical Center	Davenport	Iowa
United States	Daytona Heart Group	Daytona Beach	Florida
United States	St. Mary's Medical Center	Evansville	Indiana
United States	Northern Indiana Research Alliance	Ft. Wayne	Indiana
United States	Parkview Hospital, Inc.	Ft. Wayne	Indiana
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Arizona Advanced Arrhythmias	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	EP Heart	Houston	Texas
United States	Heart Hospital of Austin	Houston	Texas
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	First Coast Cardiovascular	Jacksonville	Florida
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	La Porte Hospital	La Porte	Indiana
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Central Baptist Hospital	Lexington	Kentucky
United States	St. Joseph Hospital	Lexington	Kentucky
United States	Baptist Health Medical Center	Little Rock	Arizona
United States	LAC & USC Medical Center	Los Angeles	California
United States	Wellstar Research Institute	Marietta	Georgia
United States	Rogue Valley Medical Center	Medford	Oregon
United States	Stern Cardiovascular Foundation, Inc.	Memphis	Tennessee
United States	Tri-City Cardiology	Mesa	Arizona
United States	Univeristy of MN Medical Center	Minneapolis	Minnesota
United States	Monongalia General Hospital	Morgantown	West Virginia
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	The Arrhythmia Institute	Newton	Pennsylvania
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	John Muir Medical Center	Oakland	California
United States	Bergan Cardiology -Alegent Bergan Mercy Medical Center	Omaha	Nebraska
United States	Orlando Heart Center	Orlando	Florida
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Cardiovascular Consultants, LTD	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	St. Elizabeth Health Center	Poland	Ohio
United States	Cardiovascular Associates of Rhode Island	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Chippenham Medical Center	Richmond	Virginia
United States	Virgina Commonwealth University Hospital System	Richmond	Virginia
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	Michigan Cardiovascular Institute	Saginaw	Michigan
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey
United States	Providence Hospital	Southfield	Michigan
United States	HealthEast St. Joseph's Hospital	St. Paul	Minnesota
United States	Northwest Ohio Cardiology	Toledo	Ohio
United States	Pima Heart Physicians, PC	Tucson	Arizona
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Washington Hospital Center	Washington	District of Columbia
United States	New Jersey Cardiology Associates	West Orange	New Jersey
United States	Buffalo Cardiology and Pulmonary	Williamsville	New Jersey
United States	Winter Haven Hospital	Winter Haven	Florida
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Milton S. Hershey Medical Center

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Malaysia,  Netherlands,  Slovakia,  Thailand,  United Kingdom, 

References & Publications (14)

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

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

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, 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, 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, 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, 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. 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

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

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Months	No