Step and Walking Pattern From Cardiac Monitor Study

Terminated

• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Insertable Cardiac Monitor
• Interventions: Device: Wearable Cardiac Monitor

• Registration Number: NCT04971993
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-22
• Study Start: 2022-01-05
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure NYHA Class II	Wearable Cardiac Monitor	Participants are diagnosed with NYHA Class II heart failure.
Heart Failure NYHA Class III	Wearable Cardiac Monitor	Participants are diagnosed with NYHA Class III heart failure.
At risk for arrythmias	Wearable Cardiac Monitor	Participants are indicated for an insertable cardiac monitor with no history of heart failure.

Primary Outcome Measures

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

Trial Locations

Locations (1)

CentraCare Heart and Vascular Clinic; 🇺🇸 Saint Cloud, Minnesota, United States