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.
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.
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Devices previously converted to the SRD-1 and withdrawn from the study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
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There are 98 Locations for this study
Anchorage Alaska, 99508, United States
Gilbert Arizona, 85297, United States
Little Rock Arizona, 77205, United States
Mesa Arizona, 85206, United States
Phoenix Arizona, 85032, United States
Tucson Arizona, 85712, United States
Tucson Arizona, 85723, United States
Jonesboro Arkansas, 72401, United States
Los Angeles California, 90033, United States
Oakland California, 94609, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Hartford Connecticut, 06102, United States
Washington District of Columbia, 20010, United States
Daytona Beach Florida, 32114, United States
Jacksonville Florida, 32216, United States
Lakeland Florida, 33805, United States
Orlando Florida, 32806, United States
Winter Haven Florida, 33881, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Gainesville Georgia, 30501, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Park Ridge Illinois, 60068, United States
Evansville Indiana, 47750, United States
Ft. Wayne Indiana, 46804, United States
Ft. Wayne Indiana, 46845, United States
Indianapolis Indiana, 46260, United States
La Porte Indiana, 46250, United States
Cedar Rapids Iowa, 52043, United States
Davenport Iowa, 52803, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40504, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Saginaw Michigan, 48601, United States
Southfield Michigan, 48075, United States
Minneapolis Minnesota, 55455, United States
St. Paul Minnesota, 55102, United States
Omaha Nebraska, 68124, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07962, United States
Sewell New Jersey, 08080, United States
West Orange New Jersey, 07052, United States
Williamsville New Jersey, 14221, United States
Bronx New York, 10467, United States
Brooklyn New York, 11215, United States
New Hyde Park New York, 11040, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28203, United States
Canton Ohio, 44708, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45220, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43215, United States
Poland Ohio, 44514, United States
Toledo Ohio, 43615, United States
Tulsa Oklahoma, 74104, United States
Medford Oregon, 26341, United States
Abington Pennsylvania, 19001, United States
Hershey Pennsylvania, 17033, United States
Lancaster Pennsylvania, 17604, United States
Newton Pennsylvania, 18940, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15213, United States
Yardley Pennsylvania, 19067, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02904, United States
Charleston South Carolina, 29425, United States
Memphis Tennessee, 38120, United States
Austin Texas, 78705, United States
Beaumont Texas, 77702, United States
Houston Texas, 77030, United States
Houston Texas, 78756, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 2911, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23219, United States
Richmond Virginia, 23225, United States
Morgantown West Virginia, 26505, United States
Brno , 65691, Czech Republic
Jena , 07747, Germany
Shatin , 99907, Hong Kong
Budapest , 1096, Hungary
Budapest , 1122, Hungary
Budapest , 1134, Hungary
Rehovot , 76100, Israel
Ancona , 60100, Italy
Negrar , 37024, Italy
Kuala Lumpur , 50400, Malaysia
Leiden , 2333 , Netherlands
Utrecht , 3584 , Netherlands
Bratislava , 83348, Slovakia
Kosice , 04011, Slovakia
Bangkok , 10400, Thailand
Bangkok , , Thailand
Clydebank , G81 4, United Kingdom
London , W1G 8, United Kingdom
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