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Step and Walking Pattern From Cardiac Monitor Study (SWAN)

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ClinicalTrials.gov Identifier: NCT04971993
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Heart Failure NYHA Class II Heart Failure NYHA Class III Insertable Cardiac Monitor Device: Wearable Cardiac Monitor

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 Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Step and Walking Pattern From Cardiac Monitor Study
Actual Study Start Date : January 5, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
Heart Failure NYHA Class II
Participants are diagnosed with NYHA Class II heart failure.
 Device: Wearable Cardiac Monitor
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.
 Device: Wearable Cardiac Monitor
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.
 Device: Wearable Cardiac Monitor
Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.


Outcome Measures
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Primary Outcome Measures :
  1. Step Detection [ Time Frame: 12 months ]
    Characterize step count in class II and III heart failure and in ICM indicated patients with no history of heart failure.

  2. Walking Patterns [ Time Frame: 12 months ]
    Characterize walking patterns in class II and III heart failure and in ICM indicated patients with no history of heart failure.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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
  • Prior hospitalization or surgery within previous 6 r weeks prior to consent.
  • Cardiovascular event such as unstable angina or myocardial infarction within previous 6 weeks prior to consent.
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971993


Contacts
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Contact: Ashley M Jensen, MS 651.582.4908 ashley.jensen@bsci.com
Contact: Pramodsingh Thakur, PhD 651.582.5863 pramodsingh.thakur@bsci.com

Locations
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United States, Minnesota
CentraCare Heart and Vascular Clinic Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Jennifer Humbert, BSN    320-251-2700 ext 57560    HumbertJ@centracare.com   
Contact: Kelly Kobylinski, RN    320-251-2700 ext 58316    kelly.kobylinski@centracare.com   
United Heart and Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Kari M Thomas, BA    612-863-7493    Kari.M.Thomas@allina.com   
Contact: Lisa Tindell, BSN    612-863-3816    lisa.tindell@allina.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Archana Rajdev, MD CentraCare Heart and Vascular Clinic
Principal Investigator: Alan Bank, MD United Heart and Vascular Clinic
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04971993    
Other Study ID Numbers: C2168
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Scientific Corporation:
exercise
walk
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases