Step and Walking Pattern From Cardiac Monitor Study

Stopped early

Conditions studied: Heart Failure NYHA Class II, Heart Failure NYHA Class III, Insertable Cardiac Monitor

In brief

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.

Key facts

Study ID

NCT04971993

Run by

Boston Scientific Corporation

People needed

40

Starts

2022-01-05

Expected to finish

2023-10-11

Last updated by the study team

2023-12-13

Who can join

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

You may qualify if…

• 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
• OR
• 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

You may not qualify if…

• Not able to walk continuously for a period of 6 minutes at the subjects baseline walking speed
• Prior hospitalization or surgery that affects the subjects baseline walking speed at time of enrollment
• Cardiovascular event such as unstable angina or myocardial infarction that affects the subjects baseline walking speed at time of enrollment
• 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).

Where it is running

• CentraCare Heart and Vascular Clinic — Saint Cloud, Minnesota, United States

Full record on ClinicalTrials.gov

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