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TERMINATED

Step and Walking Pattern From Cardiac Monitor Study

NCT04971993•Boston Scientific Corporation

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

CentraCare Heart and Vascular Clinic

Saint Cloud, Minnesota, United States

Key Dates

Start Date

January 5, 2022

Primary Completion Date

October 11, 2023

Completion Date

October 11, 2023

Last Updated

December 13, 2023

Enrollment

ACTUAL participants

Conditions

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIInsertable Cardiac Monitor

Interventions

Wearable Cardiac Monitor

DEVICE

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

NCT05647213

Univentricular HeartCongenital Heart Disease+2 more

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RECRUITINGPHASE2/PHASE3

Optimizing HFrEF Patients Using BaroStim and CardioMems

NCT07399587

Heart Failure NYHA Class III

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Step and Walking Pattern From Cardiac Monitor Study

Inclusion Criteria

Exclusion Criteria

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Optimizing HFrEF Patients Using BaroStim and CardioMems

An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)

Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure

BLOOD FLOW RESTRICTED RESISTANCE EXERCISES VERSUS LOW LEVEL LASER ON CARDIAC FUNCTIONS IN PATIENTS WITH CHRONIC HEART FAILURE