Status:
COMPLETED
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure, Systolic
Heart Failure, Diastolic
Eligibility:
All Genders
21+ years
Brief 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 si...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04112576
Start Date
July 23 2020
End Date
May 11 2022
Last Update
April 7 2023
Active Locations (3)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
National Heart Center Singapore
Singapore, Singapore, 169609
3
MacKay Memorial Hospital
Taipei, Taiwan, 10449