Clinical trial NCT04971993: Step and Walking Pattern From Cardiac Monitor Study
Official title: Step and Walking Pattern From Cardiac Monitor Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Insertable Cardiac Monitor
Keywords: exercise
walk
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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 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).

Primary outcomes:
measure: Step Detection
timeFrame: 12 months
measure: Walking Patterns
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Clinic
state: Minnesota
Study officials:
affiliation: CentraCare Heart and Vascular Clinic
name: Jamie Pelzel, MD
role: PRINCIPAL_INVESTIGATOR
References: