The Global cVAD Study (cVAD)

May 6, 2021 updated by: Abiomed Inc.
The intent of the Global cVAD Study is to utilize observational data of the ABIOMED, Inc. hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis, to serve as a tool to measure and improve the quality of patient care and to serve as a resource for future research and regulatory filings.

Study Overview

Status

Active, not recruiting

Detailed Description

Ongoing, observational, multicenter, records review of patients receiving the ABIOMED, Inc. hemodynamic support device(s). To collect in-hospital data, a waiver of consent and authorization will be requested to avoid significant biases in data reporting due to the extremely high mortality. To collect the post-discharge data on subjects who survive the index hospitalization, an informed consent will be obtained from those subjects or a waiver of informed consent will be used to collect data if the subject was implanted greater than a year from enrollment. Data will be collected through the review of existing medical records and subject telephone interview. Clinical follow-up as an office visit is not required for this study protocol. However, clinical follow-up and event-driven visits (e.g. re-hospitalizations) may occur as clinically warranted. At each follow-up time point, a telephone call to the subject will be attempted to obtain updated medical history and self-assessed cardiac function. In addition to the telephone call, the subject's medical records at the study site will be reviewed for cardiac-related clinic visits and/or cardiac-related re-hospitalization, including echocardiographic imaging. All data collected for this study will be reported on study specific electronic Case Report Forms (eCRFs) and entered into a controlled 21CFRPart11 compliant Electronic Data Capture (EDC) System by the designee at the participating site. Monitoring of the study data will be performed according to the study monitoring plan. Monitoring may be performed on-site or remotely and will not be conducted by anyone involved in data collection. A Clinical Events Committee (CEC) may be formed by the Sponsor. If convened, the CEC, an independent adjudication body composed of cardiologists and cardiac surgeons will adjudicate whether the site-reported adverse events and/or MACCE meet the study definitions for these events, and the relatedness of the events to the procedure and the device. A Steering Committee composed of internationally recognized investigators and experts in the field of interventional cardiology, cardiovascular surgery, cardiac electrophysiology, heart failure and mechanical circulatory support was established to provide technical and scientific oversight of the study.

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Health Research Institute, Banner Good Samaritan Hospital
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai
      • Los Angeles, California, United States, 90033
        • University of Southern California Keck Hospital
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
    • Florida
      • Delray Beach, Florida, United States, 33484
        • The Center for Advanced Research Excellence - Delray Medical Center
      • Jacksonville, Florida, United States, 32204
        • St. Vincent's Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33133
        • Mercy Hospital Research Institute
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Georgia
      • Augusta, Georgia, United States, 30901
        • University Cardiology Associates
      • Marietta, Georgia, United States, 30060
        • Wellstar Research Institute
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Health Services Corporation
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Corrigan Minehan Heart Center
      • Worcester, Massachusetts, United States, 01608
        • St. Vincent Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cardiovascular Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Hospital
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health Center
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt. Sinai
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Mercy Health Anderson
      • Cleveland, Ohio, United States, 44106
        • University Hospital Cleveland Medical Center
      • Dayton, Ohio, United States, 45414
        • Good Samaritan Hospital
      • Fairfield, Ohio, United States, 45014
        • Mercy Health - Fairfield Hospital Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Cardiovascular Physicians
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health Cardiovascular Institute Inc.
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson General Hospital
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75204
        • Baylor Heart and Vascular Institute
      • Fort Worth, Texas, United States, 76104
        • Plaza Medical Center of Fort Worth
      • Houston, Texas, United States, 77030
        • The University of Texas - Health Science Center & Medical School at Houston
      • Houston, Texas, United States, 77004
        • Baylor College of Medicine - TX Heart Institute
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Health System
      • Roanoke, Virginia, United States, 24014
        • Carilion Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Charleston Area Medical Center
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who received mechanical circulatory support with an ABIOMED, Inc. hemodynamic support device per treating physician's discretion and best practices will be considered eligible for enrollment. Subjects in whom an attempt was made to implant an ABIOMED, Inc. hemodynamic support device will also be included, even though the attempt was unsuccessful. An attempt is defined as the ABIOMED, Inc. hemodynamic support catheter came in contact with the subject's skin but was not successfully placed.

Description

Inclusion Criteria:

1. All subjects in the study population are eligible for enrollment at the time of receiving support from an ABIOMED, Inc. hemodynamic support device, or at the time of attempt to implant an ABIOMED, Inc. hemodynamic support device.

Exclusion Criteria:

1. Patients in whom an attempt to implant an ABIOMED, Inc. hemodynamic support device did not occur.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eligible Patients
The population to be enrolled in this study includes patients whose intended treatment is to receive mechanical circulatory support with the ABIOMED, Inc. hemodynamic support devices per the treating physician's discretion and best practices.
ABIOMED, Inc. hemodynamic support technology are the smallest and least invasive percutaneous ventricular support blood pumps available on the market. They are routinely used in clinical practice in a variety of clinical scenarios to support patients in prophylactic or emergent settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events including Major Adverse Cardiac and Cerebrovascular Events
Time Frame: January 2025
Incidence of Adverse Events including Major Adverse Cardiac and Cerebrovascular Events measured through site-reported events in study EDC through anticipatory primary completion date of January 2025.
January 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Ali Almedhychy, MD, Abiomed Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2017

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cVAD
  • USPella (Other Identifier: Abiomed, Inc.)
  • The Global cVAD Registry (Other Identifier: Abiomed, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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