Heart Failure NYHA Class IISWANNCT04971993
Step and Walking Pattern From Cardiac Monitor Study
An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Boston Scientific Corporation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Insertable Cardiac Monitor
- What is being tested?
- Wearable Cardiac Monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 11 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
CentraCare Heart and Vascular Clinic
Saint Cloud, Minnesota, 56303
About this study
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.
- Being tested
- Wearable Cardiac Monitor
- Keywords
- exercise, walk
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Cardiac MonitorDevice
Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure NYHA Class II | Participants are diagnosed with NYHA Class II heart failure. Receives: Device: Wearable Cardiac Monitor | |
| Heart Failure NYHA Class III | Participants are diagnosed with NYHA Class III heart failure. Receives: Device: Wearable Cardiac Monitor | |
| At risk for arrythmias | Participants are indicated for an insertable cardiac monitor with no history of heart failure. Receives: Device: Wearable Cardiac Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Detection
Characterize step count in class II and III heart failure and in ICM indicated patients with no history of heart failure.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start5 Jan 2022
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Why it stopped: Resourcing challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Pelzel, MD, Principal investigator, CentraCare Heart and Vascular Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971993
- Sponsor's protocol ID
- C2168
- Acronym
- SWAN
- Status last verified
- Dec 2023
- First submitted
- 28 Jun 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step and Walking Pattern From Cardiac Monitor Study
- ClinicalTrials.gov ID
- NCT04971993
- Acronym / sponsor ID
- SWAN / C2168
- Keywords
- exercise, walk
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Resourcing challenges
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart Failure NYHA Class II | – | Device: Wearable Cardiac MonitorParticipants are diagnosed with NYHA Class II heart failure. |
| Heart Failure NYHA Class III | – | Device: Wearable Cardiac MonitorParticipants are diagnosed with NYHA Class III heart failure. |
| At risk for arrythmias | – | Device: Wearable Cardiac MonitorParticipants are indicated for an insertable cardiac monitor with no history of heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardiac MonitorParticipants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals. | Device | At risk for arrythmias, Heart Failure NYHA Class II, Heart Failure NYHA Class III |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: Resourcing challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Pelzel, MD principal investigator
CentraCare Heart and Vascular Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Resourcing challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Detection (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.