Heart Failure Clinical Trial

Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Heart Failure

Estimated Enrollment:

975

Study ID:

NCT01128166

Recruitment Status:

Completed

Sponsor:

Boston Scientific Corporation

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There are 98 Locations for this study

See Locations Near You

Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Arizona Advanced Arrhythmias
Gilbert Arizona, 85297, United States
Baptist Health Medical Center
Little Rock Arizona, 77205, United States
Tri-City Cardiology
Mesa Arizona, 85206, United States
Cardiovascular Consultants, LTD
Phoenix Arizona, 85032, United States
Pima Heart Physicians, PC
Tucson Arizona, 85712, United States
Southern Arizona VA Health Care System
Tucson Arizona, 85723, United States
Cardiology Associates of Northeast Arkansas
Jonesboro Arkansas, 72401, United States
LAC & USC Medical Center
Los Angeles California, 90033, United States
John Muir Medical Center
Oakland California, 94609, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
California Pacific Medical Center
San Francisco California, 94115, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Washington Hospital Center
Washington District of Columbia, 20010, United States
Daytona Heart Group
Daytona Beach Florida, 32114, United States
First Coast Cardiovascular
Jacksonville Florida, 32216, United States
Lakeland Regional Medical Center
Lakeland Florida, 33805, United States
Orlando Heart Center
Orlando Florida, 32806, United States
Winter Haven Hospital
Winter Haven Florida, 33881, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
St Joseph's Hospital of Atlanta
Atlanta Georgia, 30342, United States
Northeast Georgia Heart Center
Gainesville Georgia, 30501, United States
Wellstar Research Institute
Marietta Georgia, 30060, United States
University of Chicago Hospital
Chicago Illinois, 60637, United States
Advocate Lutheran General Hospital
Park Ridge Illinois, 60068, United States
St. Mary's Medical Center
Evansville Indiana, 47750, United States
Northern Indiana Research Alliance
Ft. Wayne Indiana, 46804, United States
Parkview Hospital, Inc.
Ft. Wayne Indiana, 46845, United States
St. Vincent's Hospital
Indianapolis Indiana, 46260, United States
La Porte Hospital
La Porte Indiana, 46250, United States
St. Luke's Hospital
Cedar Rapids Iowa, 52043, United States
Genesis Medical Center
Davenport Iowa, 52803, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
St. Joseph Hospital
Lexington Kentucky, 40504, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
St Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Michigan Cardiovascular Institute
Saginaw Michigan, 48601, United States
Providence Hospital
Southfield Michigan, 48075, United States
Univeristy of MN Medical Center
Minneapolis Minnesota, 55455, United States
HealthEast St. Joseph's Hospital
St. Paul Minnesota, 55102, United States
Bergan Cardiology -Alegent Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Cardiovascular Associates of the Delaware Valley
Sewell New Jersey, 08080, United States
New Jersey Cardiology Associates
West Orange New Jersey, 07052, United States
Buffalo Cardiology and Pulmonary
Williamsville New Jersey, 14221, United States
Montefiore Medical Center
Bronx New York, 10467, United States
New York Methodist Hospital
Brooklyn New York, 11215, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Strong Memorial Hospital of the University of Rochester
Rochester New York, 14642, United States
Sanger Heart and Vascular Institution
Charlotte North Carolina, 28203, United States
Cardiovascular Research Institute LLC
Canton Ohio, 44708, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati Ohio, 45220, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
Columbus Ohio, 43215, United States
St. Elizabeth Health Center
Poland Ohio, 44514, United States
Northwest Ohio Cardiology
Toledo Ohio, 43615, United States
Oklahoma Heart Institute
Tulsa Oklahoma, 74104, United States
Rogue Valley Medical Center
Medford Oregon, 26341, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
The Arrhythmia Institute
Newton Pennsylvania, 18940, United States
Albert Einstein Medical Center
Philadelphia Pennsylvania, 19141, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Cardiology Consultants of Philadelphia
Yardley Pennsylvania, 19067, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Cardiovascular Associates of Rhode Island
Providence Rhode Island, 02904, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Stern Cardiovascular Foundation, Inc.
Memphis Tennessee, 38120, United States
Texas Cardiac Arrhythmia Research
Austin Texas, 78705, United States
South East Texas Clinical Research
Beaumont Texas, 77702, United States
EP Heart
Houston Texas, 77030, United States
Heart Hospital of Austin
Houston Texas, 78756, United States
University of Utah Hospital and Clinics
Salt Lake City Utah, 84112, United States
University of VA Medical Center
Charlottesville Virginia, 2911, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Virgina Commonwealth University Hospital System
Richmond Virginia, 23219, United States
Chippenham Medical Center
Richmond Virginia, 23225, United States
Monongalia General Hospital
Morgantown West Virginia, 26505, United States
Faculty Hospital U sv Anny
Brno , 65691, Czech Republic
University Hospital Jena Cardiology
Jena , 07747, Germany
Prince of Wales Hospital
Shatin , 99907, Hong Kong
Hungarian Institute of Cardiology
Budapest , 1096, Hungary
Semmelweis University, Cardiovascular Center
Budapest , 1122, Hungary
Allami Egeszsegugyi Kozpont (AEK) Hospital
Budapest , 1134, Hungary
Kaplan Medical Centre
Rehovot , 76100, Israel
Az. Osp. Lancisi
Ancona , 60100, Italy
Ospedale Sacro Cuore Don Calabria
Negrar , 37024, Italy
Institut Jantung Negara
Kuala Lumpur , 50400, Malaysia
Leiden University Medical Center
Leiden , 2333 , Netherlands
Universitair Medisch Centrum
Utrecht , 3584 , Netherlands
The National Institute of Cardiovascular Diseases - NUSCH
Bratislava , 83348, Slovakia
VUSCH a.s.
Kosice , 04011, Slovakia
Ramathibodi Hospital
Bangkok , 10400, Thailand
Her Majesty Cardiac Center, Siriraj Hospital
Bangkok , , Thailand
Golden Jubilee National Hospital
Clydebank , G81 4, United Kingdom
The Heart Hospital
London , W1G 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

975

Study ID:

NCT01128166

Recruitment Status:

Completed

Sponsor:


Boston Scientific Corporation

How clear is this clinincal trial information?

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