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TerminatedNCT04971993SWANUpdated Dec 13, 2023

Step and Walking Pattern From Cardiac Monitor Study

An observational study in Heart Failure NYHA Class II, Heart Failure NYHA Class III and Insertable Cardiac Monitor, sponsored by Boston Scientific Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Boston Scientific Corporation · Observational

Why this study was terminated
Resourcing challenges
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

Keywords

  • exercise
  • walk
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 40 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceWearable Cardiac Monitor

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

06

What researchers measure

Primary outcomes

  1. Step Detection

    Characterize step count in class II and III heart failure and in ICM indicated patients with no history of heart failure.

    Time frame: 12 months

  2. Walking Patterns

    Characterize walking patterns in class II and III heart failure and in ICM indicated patients with no history of heart failure.

    Time frame: 12 months

07

Study locations

1 site
  • CentraCare Heart and Vascular Clinic
    Saint Cloud, Minnesota 56303, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04971993
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Jul 22, 2021
Start date
Jan 5, 2022
Primary completion
Oct 11, 2023
Completion
Oct 11, 2023
Last update
Dec 13, 2023

Study contacts

Jamie Pelzel, MD
principal investigator · CentraCare Heart and Vascular Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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