Benefits of Microcor in Ambulatory Decompensated Heart Failure

Heart Failure Clinical Trial

— BMAD-TX  

Official title:

Benefits of Microcor in Ambulatory Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096040
• Other study ID #: 90D0202
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2024
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Description:

Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days. During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of μCor wear, and any health care utilization since the end of μCor wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
• 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
• 4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

• 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
• 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
• 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
• 4.2.4 Subjects anticipated to start dialysis within 90 days.
• 4.2.5 Subjects currently implanted with an S-ICD system.
• 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
• 4.2.7 Subjects who are unable to participate in all follow up visits.
• 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
• 4.2.9 Subjects currently implanted with an LVAD.
• 4.2.10 Subjects with self-reported pregnancy.
• 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• µCor
µCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt
Austria	Klinik Favoriten	Wien
France	Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique	Lille
France	CHU Montpellier - Hopital Arnaud de Villeneuve	Montpellier
France	Chu Montpellier - Hopital Arnaud de Villeneuve	Montpellier
France	Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5	Paris
France	Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5	Paris
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Universitätsklinikum Frankfurt	Frankfort
Germany	Universitätsklinikum Gießen und Marburg GmbH	Gießen
Germany	Albertinen Krankenhaus Hamburg	Hamburg
Germany	Albertinen Krankenhaus HH	Hamburg	GG
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie	Leipzig
United States	North Texas Research Associates	Allen	Texas
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Aventura Clinical Research LLC	Aventura	Florida
United States	Sinai Center for Thrombosis Reserach and Drug Development	Baltimore	Maryland
United States	BronxCare Health System at BronxCare Hospital Center	Bronx	New York
United States	Macklenberg Heart Specialists / Focus Clinical Research Solutions	Charlotte	North Carolina
United States	Virtua Health	Cherry Hill	New Jersey
United States	Columbus Cardiology Associates	Columbus	Georgia
United States	Bassett Medical Center	Cooperstown	New York
United States	North Houston Cardiology Center	Cypress	Texas
United States	Accel Research Sites - Guardian	Davenport	Florida
United States	Accel Research Sites- Daytona Heart Group	DeLand	Florida
United States	Accel Research Sites - Guardian Winter Park	Deltona	Florida
United States	Accel Research Sites - Lake County Medical Group	Eatonton	Georgia
United States	TriWest Research	El Cajon	California
United States	Holy Cross Hospital, Medical Group, Cardiology Associates	Fort Lauderdale	Florida
United States	JPS Health Network	Fort Worth	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Heart Clinic of Hammond	Hammond	Louisiana
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Elite Cardiac Research Center	Hialeah	Florida
United States	Inpatient Research Clinic	Hialeah	Florida
United States	Zillan Clinical Research	Inglewood	California
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Knoxville HMA Cardiology, PPM, LLC	Knoxville	Tennessee
United States	Carolina Heart Specialists	Lancaster	South Carolina
United States	Kansas City Cardiology	Lee's Summit	Missouri
United States	Bryan Heart	Lincoln	Nebraska
United States	Axis Clinical Trials	Los Angeles	California
United States	Norton Heart Specialists	Louisville	Kentucky
United States	Stroobants Cardiovascular Center	Lynchburg	Virginia
United States	North Texas Research Associates	McKinney	Texas
United States	Texas Institute of Cardiology	McKinney	Texas
United States	Homestead Associates in Research	Miami	Florida
United States	Westchester Research Center at Westchester General Hospital	Miami	Florida
United States	InvivoCure LLC	Mission Hills	California
United States	Cardiovascular Research of Northwest Indiana, LLC	Munster	Indiana
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Mission Research Institue	New Braunfels	Texas
United States	Mercer Bucks Cardiology at Jefferson Health	Newtown	Pennsylvania
United States	Miramax Clinical Research Inc	North Miami	Florida
United States	Ocala Cardiovascular Research	Ocala	Florida
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	Methodist Physicians Clinical Heart Consultants	Omaha	Nebraska
United States	Accel Research Sites	Orlando	Florida
United States	Research Integrity, LLC	Owensboro	Kentucky
United States	Intervent Clinical Research Center	Pembroke Hills	Maryland
United States	Cardiovascular Institute	Pittsburgh	Pennsylvania
United States	Pulse Heart Institute	Puyallup	Washington
United States	Quincy Medical Group	Quincy	Illinois
United States	Reid Physician Associates	Richmond	Indiana
United States	Ascension Providence Rochester Hospital	Rochester	Michigan
United States	Laurelton Heart Specialist	Rosedale	New York
United States	Ascension St. Mary's Research Institute	Saginaw	Michigan
United States	Gateway Cardiovascular Research Center, Inc	Saint Louis	Missouri
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	ACRC Studies	San Diego	California
United States	SYED Research Consultants LLC	Sheffield	Alabama
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Beacon Medical Group	South Bend	Indiana
United States	Heart House Research Foundation	Springfield	Ohio
United States	DBC Research	Tamarac	Florida
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio
United States	Bay Area Heart	Webster	Texas
United States	Winter Haven Hospital - BayCare Health System	Winter Haven	Florida
United States	Accel Research Sites - Guardian Winter Park	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Engagement of Device Data	Quantification of investigator actions after viewing device data.	Through study completion, an average of 2.5 years.
Secondary	Correlations of the µCor measured thoracic fluid index to heart failure related clinical events.	Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance). Clinical heart failure events will be collected in the Case Report Forms.	90 days.
Secondary	Correlations of cardiac rhythm µCor measurements to heart failure related clinical events.	Reading: cardiac rhythm measured as heart rate (beats per minute)Clinical heart failure events will be collected in the Case Report Forms.	90 days
Secondary	Correlations of respiration rate µCor measurements to heart failure related clinical events.	Reading: respiration rateClinical heart failure events will be collected in the Case Report Forms.	90 days
Secondary	Correlations of the µCor measured thoracic fluid index and heart failure related symptoms.	Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance).Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.	90 days
Secondary	Correlations of cardiac rhythm µCor measurements and heart failure related symptoms.	Reading: cardiac rhythm measured as heart rate (beats per minute)Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.	90 days.
Secondary	Correlations of respiration rate µCor measurements and heart failure related symptoms.	Reading: respiration rate. Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.	90 days
Secondary	Incident Rate; Hospital Readmission	Rate of hospital readmission captured in the Case Report Forms.	90 days, 6 months, 1 year
Secondary	Incident Rate; Physician Visit	Rate of physician visits captured in the Case Report Forms.	90 days, 6 months, 1 year
Secondary	Incident Rate; Outpatient Clinic Visit	Rate of outpatient clinic visits captured in the Case Report Forms.	90 days, 6 months, 1 year
Secondary	Mortality; Rate	Mortality Rate; number of subject deaths captured in the Case Report Forms	90 days, 6 months, 1 year
Secondary	Mortality; Cause of Death	Cause of Death; clinical history captured in the Case Report Forms	90 days, 6 months, 1 year
Secondary	Quality of Life by Patient Security Questionnaire	Quality of Life; measured through and Patient Health Security Questionnaire.	90 days, 6 months, 1 year
Secondary	Quality of Life by Kansas City Heart Questionnaire	Quality of Life; measured through Kansas City Heart Failure Questionnaire.	90 days, 6 months, 1 year
Secondary	Health Care Utilization by Cost Estimate	Health Care Utilization; measured through cost estimates of prescription medications.	90 days, 6 months, 1 year
Secondary	Health Care Utilization by Frequency of Prescription Medication Use.	Health Care Utilization; measured through frequency of prescription medication use reported on the Case Report Forms.	90 days, 6 months, 1 year
Secondary	Health Care Utilization by Frequency of Hospital Visits.	Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms.	90 days, 6 months, 1 year
Secondary	Health Care Utilization by Frequency of ER visits.	Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms.	90 days, 6 months, 1 year
Secondary	Health Care Utilization by Frequency of physician visits.	Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms.	90 days, 6 months, 1 year