An observational study in Heart Failure, Systolic and Heart Failure, Diastolic, sponsored by Boston Scientific Corporation. Completed at 3 sites in 3 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Boston Scientific Corporation · Observational
To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).
To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function
This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.
There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. 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 100 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.
Patients that are diagnosed with NYHA class II or III heart failure with preserved or reduced ejection fraction.
Exclusion Criteria:
Participants that are diagnosed with NYHA class II or III heart failure with reduced ejection fraction.
Device: Wearable cardiac monitor
Participants that are diagnosed with NYHA class II or III heart failure with preserved ejection fraction.
Device: Wearable cardiac monitor
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
Physiologic Signal Detection
Characterize differences in cardiac physiology and dynamics between heart failure with preserved ejection fraction and heart failure with reduced ejection fraction patient populations using a wearable cardiac monitor prototype device.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation