Step and Walking Pattern From Cardiac Monitor Study

Heart Failure NYHA Class III Clinical Trial

— SWAN  

Official title:

Step and Walking Pattern From Cardiac Monitor Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04971993
• Other study ID #: C2168
• Status: Terminated
• Start date: January 5, 2022
• Est. completion date: October 11, 2023

Study information

• Verified date: December 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Device:
• Wearable Cardiac Monitor
Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.

Locations

Country	Name	City	State
United States	CentraCare Heart and Vascular Clinic	Saint Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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