NCT04971993

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

June 28, 2021

Last Update Submit

December 7, 2023

Conditions

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIInsertable Cardiac Monitor

Keywords

exercisewalk

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Heart Failure NYHA Class II

Participants are diagnosed with NYHA Class II heart failure.

Device: Wearable Cardiac Monitor

Heart Failure NYHA Class III

Participants are diagnosed with NYHA Class III heart failure.

Device: Wearable Cardiac Monitor

At risk for arrythmias

Participants are indicated for an insertable cardiac monitor with no history of heart failure.

Device: Wearable Cardiac Monitor

Interventions

Wearable Cardiac MonitorDEVICE

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

At risk for arrythmiasHeart Failure NYHA Class IIHeart Failure NYHA Class III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CentraCare Heart and Vascular Clinic

Saint Cloud, Minnesota, 56303, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jamie Pelzel, MD

    CentraCare Heart and Vascular Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 22, 2021

Study Start

January 5, 2022

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)