Nanowear Heart Failure Management Multi-sensor Algorithm (Nanosense)
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|ClinicalTrials.gov Identifier: NCT03719079|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: SimpleSENSE|
NanoSense is a data collection study to develop a multi-sensor algorithm to predict worsening Heart Failure (HF). Subjects who meet the eligibility criteria and agree to participate in the study will enter the informed consent process in which the subject will be informed about the research study, the voluntary nature of the research and all attendant risks and benefits. Once the subject has been informed and all question answered, the subject will be asked to sign an informed consent document (approved by the local Institutional Review Board). At enrollment, data about subject demographics, cardiac disease history, and comorbidities will be collected. The subject vital signs, blood labs (as available; if an N-terminal pro b-type natriuretic peptide (NT-proBNP) is not available, one will be ordered to coincide with the next lab samples), HF medications and HF assessment measurements will be made and recorded. Subjects will be given a diary to record daily weights, diuretics changes, and weekly HF status. The subject will be fitted with a Nanowear Wearable Congestive Heart Failure System (WCHFS) and educated on the use of the system with attention to proper fit and changing or charging the battery daily depending on the type of battery used. Subjects who have a pacemaker or Implantable Cardioverter Defibrillator (ICD) will undergo pacemaker/ICD interrogation while wearing the device to assure that there are no electrical signals detected that may interfere with pacemaker or ICD function.
The subjects will be asked to wear the device for approximately 12 hours daily including 2 hours prior to sleep and 2 hours after awakening. The follow-up period will be 90 days. At visit 2, the clinical assessment will be repeated and recorded. The device will be retrieved from the subject. In the event that a subject is unable to travel to the investigator's site, the subject will be asked to mail the device back to the sponsor with use of a prepaid mailing package that will be delivered to the subject. Data may be obtained by phone if the subject is unable or unwilling to return for visit 2.
A final contact will be made to the subject at 30 days following visit 2 to determine whether there were any adverse effects that were not previously recognized that may be related to their participation in the study.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial|
|Actual Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Heart Failure Patients
Patients with primary diagnosis as heart failure
The Nanosense study is observational only. No interventions will be triggered by the SimpleSense device
- Multi-parameter algorithm [ Time Frame: 90 days per patient and till 100 Heart Failure events are observed overall. ]The primary objective of the study is to develop and validate a multi-parameter algorithm for the detection of heart failure prior to a HF event. For the purpose of this study, a heart failure event will be defined as a hospitalization with a primary diagnosis of heart failure.
- Exploratory comparison of signals from device to NT-proBNP [ Time Frame: 90 days per patient and till 100 Heart Failure events are observed overall. ]Exploratory information will be used to compare the signals obtained from the device to the severity of heart failure as measured by clinical evaluation (NYHA functional class and physical examination) and NT-proBNP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719079
|Contact: John P Boehmer, M.D.||email@example.com|
|Contact: Venkatesh Varadanfirstname.lastname@example.org|
|United States, New Jersey|
|Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Patricia Arakelian, RN, BSN, CCRP 551-996-5722 Patricia.Arakelian@hackensackmeridian.org|
|Principal Investigator: Robert Berkowitz, MD|
|Sub-Investigator: Bernard Kim, MD|
|Sub-Investigator: Kumar Satya, MD|
|Sub-Investigator: David Silber, MD|
|Principal Investigator:||John P Boehmer, M.D.||Milton S. Hershey Medical Center|