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Benefits of Microcor in Ambulatory Decompensated Heart Failure (BMAD-TX)

Primary Purpose

Heart Failure

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
μCor
Sponsored by
Zoll Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SYED Research Consultants LLC
  • TriWest Research
  • Zillan Clinical Research
  • Axis Clinical Trials
  • InvivoCure LLC
  • ACRC Studies
  • Aventura Clinical Research LLC
  • Accel Research Sites - Guardian
  • Accel Research Sites- Daytona Heart Group
  • Accel Research Sites - Guardian Winter Park
  • Holy Cross Hospital, Medical Group, Cardiology Associates
  • Elite Cardiac Research Center
  • Inpatient Research Clinic
  • Homestead Associates in Research
  • Westchester Research Center at Westchester General Hospital
  • Miramax Clinical Research Inc
  • Ocala Cardiovascular Research
  • Accel Research Sites
  • DBC Research
  • Winter Haven Hospital - BayCare Health System
  • Accel Research Sites - Guardian Winter Park
  • Emory University School of Medicine
  • Columbus Cardiology Associates
  • Accel Research Sites - Lake County Medical Group
  • Quincy Medical Group
  • Cardiovascular Research of Northwest Indiana, LLC
  • Reid Physician Associates
  • Beacon Medical Group
  • Norton Heart Specialists
  • Research Integrity, LLC
  • Heart Clinic of Hammond
  • Sinai Center for Thrombosis Reserach and Drug Development
  • Intervent Clinical Research Center
  • Peninsula Regional Medical Center
  • Ascension Providence Rochester Hospital
  • Ascension St. Mary's Research Institute
  • Jackson Heart Clinic
  • Kansas City Cardiology
  • Gateway Cardiovascular Research Center, Inc
  • St. Louis Heart and Vascular
  • Bryan Heart
  • Methodist Physicians Clinical Heart Consultants
  • Virtua Health
  • Hackensack University Medical Center
  • Jersey Shore University Medical Center
  • BronxCare Health System at BronxCare Hospital Center
  • Bassett Medical Center
  • Laurelton Heart Specialist
  • Macklenberg Heart Specialists / Focus Clinical Research Solutions
  • Heart House Research Foundation
  • Mercy Health St. Vincent Medical Center
  • INTEGRIS Baptist Medical Center
  • Penn State Health Milton S. Hershey Medical Center
  • Mercer Bucks Cardiology at Jefferson Health
  • Cardiovascular Institute
  • Frontier Clinical Research, LLC
  • Carolina Heart Specialists
  • Knoxville HMA Cardiology, PPM, LLC
  • North Texas Research Associates
  • North Houston Cardiology Center
  • JPS Health Network
  • North Texas Research Associates
  • Texas Institute of Cardiology
  • Mission Research Institue
  • Bay Area Heart
  • Stroobants Cardiovascular Center
  • Pulse Heart Institute
  • Klinikum Klagenfurt am Wörthersee
  • Klinik Favoriten
  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique
  • CHU Montpellier - Hopital Arnaud de Villeneuve
  • Chu Montpellier - Hopital Arnaud de Villeneuve
  • Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
  • Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
  • Albertinen Krankenhaus HH
  • Kerckhoff-Klinik GmbH
  • Kerckhoff-Klinik GmbH
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Gießen und Marburg GmbH
  • Albertinen Krankenhaus Hamburg
  • Medizinische Hochschule Hannover
  • Medizinische Hochschule Hannover
  • Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Data Engagement Assessment

Arm Description

This arm will assess the endpoints of investigator engagement with the device data.

Outcomes

Primary Outcome Measures

Investigator Engagement of Device Data
Quantification of investigator actions after viewing device data.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Incident Rate; Hospital Readmission
Rate of hospital readmission captured in the Case Report Forms.
Incident Rate; Physician Visit
Rate of physician visits captured in the Case Report Forms.
Incident Rate; Outpatient Clinic Visit
Rate of outpatient clinic visits captured in the Case Report Forms.
Mortality; Rate
Mortality Rate; number of subject deaths captured in the Case Report Forms
Mortality; Cause of Death
Cause of Death; clinical history captured in the Case Report Forms
Quality of Life by Patient Security Questionnaire
Quality of Life; measured through and Patient Health Security Questionnaire.
Quality of Life by Kansas City Heart Questionnaire
Quality of Life; measured through Kansas City Heart Failure Questionnaire.
Health Care Utilization by Cost Estimate
Health Care Utilization; measured through cost estimates of prescription medications.
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.
Health Care Utilization by Frequency of Hospital Visits.
Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms.
Health Care Utilization by Frequency of ER visits.
Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms.
Health Care Utilization by Frequency of physician visits.
Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms.

Full Information

First Posted
September 12, 2019
Last Updated
July 13, 2023
Sponsor
Zoll Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04096040
Brief Title
Benefits of Microcor in Ambulatory Decompensated Heart Failure
Acronym
BMAD-TX
Official Title
Benefits of Microcor in Ambulatory Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Osz
Organizational Affiliation
Zoll Medical Corporation
Official's Role
Study Director
Facility Information:
Facility Name
SYED Research Consultants LLC
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
TriWest Research
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Zillan Clinical Research
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
InvivoCure LLC
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
ACRC Studies
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Aventura Clinical Research LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Accel Research Sites - Guardian
City
Davenport
State/Province
Florida
ZIP/Postal Code
33837
Country
United States
Facility Name
Accel Research Sites- Daytona Heart Group
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Accel Research Sites - Guardian Winter Park
City
Deltona
State/Province
Florida
ZIP/Postal Code
32725
Country
United States
Facility Name
Holy Cross Hospital, Medical Group, Cardiology Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Elite Cardiac Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Inpatient Research Clinic
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Homestead Associates in Research
City
Miami
State/Province
Florida
ZIP/Postal Code
32032
Country
United States
Facility Name
Westchester Research Center at Westchester General Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Miramax Clinical Research Inc
City
North Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Ocala Cardiovascular Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Accel Research Sites
City
Orlando
State/Province
Florida
ZIP/Postal Code
32837
Country
United States
Facility Name
DBC Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Winter Haven Hospital - BayCare Health System
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Accel Research Sites - Guardian Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Columbus Cardiology Associates
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Accel Research Sites - Lake County Medical Group
City
Eatonton
State/Province
Georgia
ZIP/Postal Code
31024
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Cardiovascular Research of Northwest Indiana, LLC
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Reid Physician Associates
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Beacon Medical Group
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Norton Heart Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Heart Clinic of Hammond
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Sinai Center for Thrombosis Reserach and Drug Development
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21784
Country
United States
Facility Name
Intervent Clinical Research Center
City
Pembroke Hills
State/Province
Maryland
ZIP/Postal Code
33024
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Ascension Providence Rochester Hospital
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Ascension St. Mary's Research Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
48601
Country
United States
Facility Name
Kansas City Cardiology
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Gateway Cardiovascular Research Center, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
St. Louis Heart and Vascular
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Methodist Physicians Clinical Heart Consultants
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Virtua Health
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
BronxCare Health System at BronxCare Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Bassett Medical Center
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Laurelton Heart Specialist
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
Macklenberg Heart Specialists / Focus Clinical Research Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Heart House Research Foundation
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Mercy Health St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Mercer Bucks Cardiology at Jefferson Health
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Cardiovascular Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Carolina Heart Specialists
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
77598
Country
United States
Facility Name
Knoxville HMA Cardiology, PPM, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
North Texas Research Associates
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
North Houston Cardiology Center
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
North Texas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Texas Institute of Cardiology
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Mission Research Institue
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Bay Area Heart
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Pulse Heart Institute
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Klinik Favoriten
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hopital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Chu Montpellier - Hopital Arnaud de Villeneuve
City
Montpellier
Country
France
Facility Name
Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
City
Paris
Country
France
Facility Name
Albertinen Krankenhaus HH
City
Hamburg
State/Province
GG
ZIP/Postal Code
22457
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
06032
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfort
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Albertinen Krankenhaus Hamburg
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie
City
Leipzig
ZIP/Postal Code
4289
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Benefits of Microcor in Ambulatory Decompensated Heart Failure

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