Step and Walking Pattern From Cardiac Monitor Study

NCT ID: NCT04971993

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2023-10-11

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III; Insertable Cardiac Monitor

Keywords

exercise; walk

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Failure NYHA Class II

Participants are diagnosed with NYHA Class II heart failure.

Wearable Cardiac Monitor

Intervention Type: DEVICE

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.

Wearable Cardiac Monitor

Intervention Type: DEVICE

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.

Wearable Cardiac Monitor

Intervention Type: DEVICE

Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.

Interventions

Wearable Cardiac Monitor

Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie Pelzel, MD

Role: PRINCIPAL_INVESTIGATOR

CentraCare Heart and Vascular Clinic

Locations

CentraCare Heart and Vascular Clinic

Saint Cloud, Minnesota, United States

Countries

United States

Other Identifiers

C2168

Identifier Type: -

Identifier Source: org_study_id