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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: ABIOMED, Inc. hemodynamic support devices
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abiomed Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yale University
Beth Israel Deaconess Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on ABIOMED, Inc. hemodynamic support devices

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings