Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices
- Conditions
- Heart Failure
- Interventions
- Device: COGNIS CRT-D
- Registration Number
- NCT01128166
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 975
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients implanted with a CRT-D (Cardiac Resynch. Therapy) COGNIS CRT-D -
- Primary Outcome Measures
Name Time Method Heart Failure (HF) events 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (99)
St. Vincent's Hospital
🇺🇸Indianapolis, Indiana, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Arizona Advanced Arrhythmias
🇺🇸Gilbert, Arizona, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
First Coast Cardiovascular
🇺🇸Jacksonville, Florida, United States
St. Mary's Medical Center
🇺🇸Evansville, Indiana, United States
HealthEast St. Joseph's Hospital
🇺🇸St. Paul, Minnesota, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Sewell, New Jersey, United States
Sanger Heart and Vascular Institution
🇺🇸Charlotte, North Carolina, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Cardiology Consultants of Philadelphia
🇺🇸Yardley, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Cardiovascular Associates of Rhode Island
🇺🇸Providence, Rhode Island, United States
Heart Hospital of Austin
🇺🇸Houston, Texas, United States
The National Institute of Cardiovascular Diseases - NUSCH
🇸🇰Bratislava, Slovakia
Golden Jubilee National Hospital
🇬🇧Clydebank, United Kingdom
Her Majesty Cardiac Center, Siriraj Hospital
🇹ðŸ‡Bangkok, Thailand
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand
Orlando Heart Center
🇺🇸Orlando, Florida, United States
St Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Tri-City Cardiology
🇺🇸Mesa, Arizona, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arizona, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Pima Heart Physicians, PC
🇺🇸Tucson, Arizona, United States
Cardiology Associates of Northeast Arkansas
🇺🇸Jonesboro, Arkansas, United States
Daytona Heart Group
🇺🇸Daytona Beach, Florida, United States
LAC & USC Medical Center
🇺🇸Los Angeles, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
John Muir Medical Center
🇺🇸Oakland, California, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Wellstar Research Institute
🇺🇸Marietta, Georgia, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Winter Haven Hospital
🇺🇸Winter Haven, Florida, United States
St Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
St. Joseph Hospital
🇺🇸Lexington, Kentucky, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Northern Indiana Research Alliance
🇺🇸Ft. Wayne, Indiana, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
La Porte Hospital
🇺🇸La Porte, Indiana, United States
Parkview Hospital, Inc.
🇺🇸Ft. Wayne, Indiana, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Cardiovascular Research Institute LLC
🇺🇸Canton, Ohio, United States
Az. Osp. Lancisi
🇮🇹Ancona, Italy
Strong Memorial Hospital of the University of Rochester
🇺🇸Rochester, New York, United States
Kaplan Medical Centre
🇮🇱Rehovot, Israel
Hungarian Institute of Cardiology
ðŸ‡ðŸ‡ºBudapest, Hungary
Allami Egeszsegugyi Kozpont (AEK) Hospital
ðŸ‡ðŸ‡ºBudapest, Hungary
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Michigan Cardiovascular Institute
🇺🇸Saginaw, Michigan, United States
New Jersey Cardiology Associates
🇺🇸West Orange, New Jersey, United States
Buffalo Cardiology and Pulmonary
🇺🇸Williamsville, New Jersey, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Stern Cardiovascular Foundation, Inc.
🇺🇸Memphis, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Rogue Valley Medical Center
🇺🇸Medford, Oregon, United States
St. Elizabeth Health Center
🇺🇸Poland, Ohio, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Northwest Ohio Cardiology
🇺🇸Toledo, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Monongalia General Hospital
🇺🇸Morgantown, West Virginia, United States
VUSCH a.s.
🇸🇰Kosice, Slovakia
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Universitair Medisch Centrum
🇳🇱Utrecht, Netherlands
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
EP Heart
🇺🇸Houston, Texas, United States
South East Texas Clinical Research
🇺🇸Beaumont, Texas, United States
University Hospital Jena Cardiology
🇩🇪Jena, Germany
Institut Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
University of VA Medical Center
🇺🇸Charlottesville, Virginia, United States
Semmelweis University, Cardiovascular Center
ðŸ‡ðŸ‡ºBudapest, Hungary
Faculty Hospital U sv Anny
🇨🇿Brno, Czech Republic
The Heart Hospital
🇬🇧London, United Kingdom
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
The Arrhythmia Institute
🇺🇸Newton, Pennsylvania, United States
Cardiovascular Consultants, LTD
🇺🇸Phoenix, Arizona, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Univeristy of MN Medical Center
🇺🇸Minneapolis, Minnesota, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Bergan Cardiology -Alegent Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
University of Utah Hospital and Clinics
🇺🇸Salt Lake City, Utah, United States
Virgina Commonwealth University Hospital System
🇺🇸Richmond, Virginia, United States
Chippenham Medical Center
🇺🇸Richmond, Virginia, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Prince of Wales Hospital
ðŸ‡ðŸ‡°Shatin, Hong Kong