Heart Failure Clinical Trial
Step and Walking Pattern From Cardiac Monitor Study
To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.
This is a non-randomized, feasibility study that will enroll up to 60 participants diagnosed with Class II (30-35%) or III (30-35%) heart failure or are indicated for an insertable cardiac monitor with no history of heart failure (30-35%).
There will be one study visit per participant and a follow up phone call. The study visit includes device placement and data collection during rest and during a 6 minute hall walk. The device will then be removed.
Subject is 18 years or older
Willing and capable to provide written informed consent and agrees to participate in all protocol required activities
Subjects must meet one of the following criteria:
Documented New York Heart Association (NYHA) class II or III heart failure within the last 6 months
Subjects that have a known heart condition (non-heart failure) and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain and/or shortness of breath
Not able to walk continuously for a period of 6 minutes
Prior hospitalization or surgery within previous 6 r weeks prior to consent.
Cardiovascular event such as unstable angina or myocardial infarction within previous 6 weeks prior to consent.
Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system
Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
Subject is pregnant as indicated by subject report and/or medical record at the time of enrollment
Subjects with rash or open wound on torso locations where investigational devices will be placed
Have an active implantable device
Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator
Any medical signs or symptoms that in the opinion of the investigator could represent a risk for the subject (I.e. increased baseline blood pressure or heart rate).
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There are 2 Locations for this study
Saint Cloud Minnesota, 56303, United States More Info
Saint Paul Minnesota, 55102, United States More Info
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