Benefits of Microcor in Ambulatory Decompensated Heart Failure

NCT04096040 | Completed Results FDA Device

• 1 other identifier: 90D0202
• Study Type: interventional
• Target: 265
• Locations: 4 countries
• Sites: 83

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (8)

• Number of Data Updates Received by the uCor Subject Management System

  Each time a subject's thoracic fluid index (TFI) exceeded a threshold for 3 consecutive days, a data update report was generated by the uCor management system. The site then confirmed its receipt of the data update by completing a case report form. At least 1 of these case report forms was completed for 56 subjects.

  90 days

• Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2)

  Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. Sites reported whether they spent less than 5, 5 to 10, or greater than 10 minutes reviewing each report. At least 1 of these case report forms was completed for 214 subjects.

  90 days

• Approximate Time Spent Reviewing Data Reports Assessment Within Sites (PO 2: Part 2/2)

  Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. Sites reported whether they spent less than 5, 5 to 10, or greater than 10 minutes reviewing each report. At least 1 of these case report forms was completed for 214 subjects.

  90 days

• The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 1/3)

  Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects

  90 days

• The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 2/3)

  Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects.

  90 days

• The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 3/3)

  Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects

  90 days

• The Number of Medication Changes Based on Subject Incidental Findings

  During weekly planned phone calls, planned office visits, and unplanned office visits, sites asked subjects whether they underwent any changes to their heart failure and/or cardiac medications since the last phone call and reported the result in a case report form. At least 1 of these case report forms was completed for 241 subjects.

  90 days

• Number of Times High μCor Measurements Were Reduced Below Threshold Levels After Medication Was Titrated or Lifestyle Modifications Were Recommended

  482 medication changes or lifestyle (MC/LS) modifications occurred within the first 90 days of the study. To include only medication changes preceded and followed by sufficient µCor data to determine a threshold crossing, medication changes within the first 2 weeks of the study or the final 3 weeks of device wear were discarded. This resulted in in 262 analyzable changes. Changes occurring within 1 week of another change were grouped together. This resulted in 192 change events. Time windows were defined as 0-13 days before the first change in a change event vs. 8-21 days after the last change in a change event. A high μCor measurement was defined as the receipt of a data update by the site. A low μCor measurement was defined as the absence of a data update received by the site.

  90 days

Secondary Outcomes (8)

• Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events.

  90 days

• Strength of Association Between μCor Measurements and Subject Reported Symptoms

  90 days

• Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms

  90 days

• Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period

  90 days

• Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Mortality Data

  6 months and 1 year

Study Arms (1)

Device Data Engagement Assessment

EXPERIMENTAL

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

Device: μCor

Interventions

μCor DEVICE

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.

Device Data Engagement Assessment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
• 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
• Subjects 21 years of age or older on the day of screening.

You may not qualify if:

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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (83)

SYED Research Consultants LLC

Sheffield, Alabama, 35660, United States

Location

TriWest Research

El Cajon, California, 92020, United States

Location

Zillan Clinical Research

Inglewood, California, 90301, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

InvivoCure LLC

Mission Hills, California, 91345, United States

Location

ACRC Studies

San Diego, California, 92119, United States

Location

Aventura Clinical Research LLC

Aventura, Florida, 33180, United States

Location

Accel Research Sites - Guardian

Davenport, Florida, 33837, United States

Location

Accel Research Sites- Daytona Heart Group

DeLand, Florida, 32720, United States

Location

Accel Research Sites - Guardian Winter Park

Deltona, Florida, 32725, United States

Location

Holy Cross Hospital, Medical Group, Cardiology Associates

Fort Lauderdale, Florida, 33308, United States

Location

Elite Cardiac Research Center

Hialeah, Florida, 33013, United States

Location

Inpatient Research Clinic

Hialeah, Florida, 33013, United States

Location

Homestead Associates in Research

Miami, Florida, 32032, United States

Location

Westchester Research Center at Westchester General Hospital

Miami, Florida, 33155, United States

Location

Miramax Clinical Research Inc

North Miami, Florida, 33169, United States

Location

Ocala Cardiovascular Research

Ocala, Florida, 34471, United States

Location

Accel Research Sites

Orlando, Florida, 32837, United States

Location

DBC Research

Tamarac, Florida, 33321, United States

Location

Winter Haven Hospital - BayCare Health System

Winter Haven, Florida, 33880, United States

Location

Accel Research Sites - Guardian Winter Park

Winter Park, Florida, 32792, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Columbus Cardiology Associates

Columbus, Georgia, 31904, United States

Location

Accel Research Sites - Lake County Medical Group

Eatonton, Georgia, 31024, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Cardiovascular Research of Northwest Indiana, LLC

Munster, Indiana, 46321, United States

Location

Reid Physician Associates

Richmond, Indiana, 47374, United States

Location

Beacon Medical Group

South Bend, Indiana, 46601, United States

Location

Norton Heart Specialists

Louisville, Kentucky, 40205, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Heart Clinic of Hammond

Hammond, Louisiana, 70403, United States

Location

Sinai Center for Thrombosis Reserach and Drug Development

Baltimore, Maryland, 21784, United States

Location

Intervent Clinical Research Center

Pembroke Hills, Maryland, 33024, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21804, United States

Location

Ascension Providence Rochester Hospital

Rochester, Michigan, 48307, United States

Location

Ascension St. Mary's Research Institute

Saginaw, Michigan, 48601, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 48601, United States

Location

Kansas City Cardiology

Lee's Summit, Missouri, 64064, United States

Location

Gateway Cardiovascular Research Center, Inc

St Louis, Missouri, 63128, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Methodist Physicians Clinical Heart Consultants

Omaha, Nebraska, 68114, United States

Location

Virtua Health

Cherry Hill, New Jersey, 08034, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Bassett Medical Center

Cooperstown, New York, 13326, United States

Location

Laurelton Heart Specialist

Rosedale, New York, 11422, United States

Location

BronxCare Health System at BronxCare Hospital Center

The Bronx, New York, 10457, United States

Location

Macklenberg Heart Specialists / Focus Clinical Research Solutions

Charlotte, North Carolina, 28207, United States

Location

Heart House Research Foundation

Springfield, Ohio, 45504, United States

Location

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Mercer Bucks Cardiology at Jefferson Health

Newtown, Pennsylvania, 18940, United States

Location

Cardiovascular Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

Carolina Heart Specialists

Lancaster, South Carolina, 77598, United States

Location

Knoxville HMA Cardiology, PPM, LLC

Knoxville, Tennessee, 37934, United States

Location

North Texas Research Associates

Allen, Texas, 75013, United States

Location

North Houston Cardiology Center

Cypress, Texas, 77429, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

North Texas Research Associates

McKinney, Texas, 75071, United States

Location

Texas Institute of Cardiology

McKinney, Texas, 75071, United States

Location

Mission Research Institue

New Braunfels, Texas, 78130, United States

Location

Bay Area Heart

Webster, Texas, 77598, United States

Location

Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

Location

Pulse Heart Institute

Puyallup, Washington, 98372, United States

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Klinik Favoriten

Vienna, 1100, Austria

Location

Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique

Lille, 59037, France

Location

CHU Montpellier - Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Chu Montpellier - Hopital Arnaud de Villeneuve

Montpellier, France

Location

Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5

Paris, 75015, France

Location

Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5

Paris, France

Location

Albertinen Krankenhaus HH

Hamburg, GG, 22457, Germany

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 06032, Germany

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

Location

Albertinen Krankenhaus Hamburg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie

Leipzig, 4289, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This study was conducted from 11/1/2019 to 6/30/2023 and partially overlapped with the COVID-19 Pandemic.

Results Point of Contact

• Title: Director of Scientific Affairs
• Organization: ZOLL Medical

nbianco@zoll.com

4129683333

Study Officials

• Mike Osz

  Zoll Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 19, 2019
• Study Start: November 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 8, 2025
• Results First Posted: October 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9); AU (2); US (67); FR (5)