Step and Walking Pattern From Cardiac Monitor Study (SWAN)

Boston Scientific

Status

Terminated

Conditions

Heart Failure NYHA Class II

Insertable Cardiac Monitor

Heart Failure NYHA Class III

Treatments

Device: Wearable Cardiac Monitor

Study type

Observational

Funder types

Industry

Identifiers

NCT04971993

C2168

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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).