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
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.
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.
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 →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.
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.
OR
Exclusion Criteria:
Participants are diagnosed with NYHA Class II heart failure.
Device: Wearable Cardiac Monitor
Participants are diagnosed with NYHA Class III heart failure.
Device: Wearable Cardiac Monitor
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
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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Boston Scientific Corporation