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CompletedNCT04112576HAPI-HFUpdated Apr 7, 2023

Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
21 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Heart Failure, Systolic
  • Heart Failure, Diastolic

Keywords

  • echocardiogram
03

In context

Heart Failure

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients that are diagnosed with NYHA class II or III heart failure with preserved or reduced ejection fraction.

Inclusion criteria

  • Patients with NYHA class II or III heart failure defined by symptoms and signs of heart failure
  • Documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
  • HFrEF defined by documented evidence of EF ≤ 40% OR
  • HFpEF defined by documented evidence of:
  • EF ≥ 50% and no prior record of EF \< 40%
  • Evidence of relevant structural heart disease or diastolic dysfunction on echocardiographic as defined in the 2016 ESC guidelines
  • Able to understand and willing to provide written informed consent to participate in the trial
  • Age 21 years old or greater
  • Willing and able to participate in the required testing

Exclusion criteria

Exclusion Criteria:

  • Prior hospitalization, CV event or surgery within 6 weeks
  • Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs.
  • Patients with Active Implantable Medical Devices
  • Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
  • Have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease
  • Subject is pregnant as indicated by patient record
  • Patients with rash or open wound on torso locations where investigational devices will be placed
  • Patient deemed as clinically unstable or unsuitable to perform prescribed testing as judged by the local investigator
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • HFrEF

    Participants that are diagnosed with NYHA class II or III heart failure with reduced ejection fraction.

    Device: Wearable cardiac monitor

  • HFpEF

    Participants that are diagnosed with NYHA class II or III heart failure with preserved ejection fraction.

    Device: Wearable cardiac monitor

Interventions

  • DeviceWearable cardiac monitor

    Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

3 sites
  • Northwestern University
    Chicago, Illinois 60611, United States
  • National Heart Center Singapore
    Singapore, 169609, Singapore
  • MacKay Memorial Hospital
    Taipei City, 10449, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04112576
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Oct 2, 2019
Start date
Jul 23, 2020
Primary completion
May 11, 2022
Completion
May 11, 2022
Last update
Apr 7, 2023

Study contacts

Carolyn Lam, MD
principal investigator · National Heart Center Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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