Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

Completed

Conditions studied: Heart Failure

In brief

The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

Key facts

Study ID

NCT01128166

Run by

Boston Scientific Corporation

People needed

975

Starts

2010-06-01

Expected to finish

2015-07-01

Last updated by the study team

2015-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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• Devices previously converted to the SRD-1 and withdrawn from the study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

Where it is running

• Arizona Advanced Arrhythmias — Gilbert, Arizona, United States
• Baptist Health Medical Center — Little Rock, Arizona, United States
• Tri-City Cardiology — Mesa, Arizona, United States
• Cardiovascular Consultants, LTD — Phoenix, Arizona, United States
• Pima Heart Physicians, PC — Tucson, Arizona, United States
• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• Cardiology Associates of Northeast Arkansas — Jonesboro, Arkansas, United States
• LAC & USC Medical Center — Los Angeles, California, United States
• John Muir Medical Center — Oakland, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Daytona Heart Group — Daytona Beach, Florida, United States
• First Coast Cardiovascular — Jacksonville, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• Orlando Heart Center — Orlando, Florida, United States
• Winter Haven Hospital — Winter Haven, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• St Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Northeast Georgia Heart Center — Gainesville, Georgia, United States
• Wellstar Research Institute — Marietta, Georgia, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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