Step and Walking Pattern From Cardiac Monitor Study (SWAN)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Insertable Cardiac Monitor
• Intervention / Treatment: Device: Wearable Cardiac Monitor

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart and Vascular Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are diagnosed with NYHA class II heart failure, class III heart failure or are indicated for an ICM with no history of heart failure.

Description

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

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

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart Failure NYHA Class II; Participants are diagnosed with NYHA Class II heart failure.	Device: Wearable Cardiac Monitor; Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.
Heart Failure NYHA Class III; Participants are diagnosed with NYHA Class III heart failure.	Device: Wearable Cardiac Monitor; Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.
At risk for arrythmias; Participants are indicated for an insertable cardiac monitor with no history of heart failure.	Device: Wearable Cardiac Monitor; Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Detection	Characterize step count in class II and III heart failure and in ICM indicated patients with no history of heart failure.	12 months
Walking Patterns	Characterize walking patterns in class II and III heart failure and in ICM indicated patients with no history of heart failure.	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jamie Pelzel, MD, CentraCare Heart and Vascular Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; walk
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: C2168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No