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

Heart Failure, Systolic Clinical Trial

— HAPI-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112576
• Other study ID #: C2116
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: May 11, 2022

Study information

• Verified date: April 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic

Intervention

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

Locations

Country	Name	City	State
Singapore	National Heart Center Singapore	Singapore
Taiwan	MacKay Memorial Hospital	Taipei City
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months