The Global cVAD Study

NCT ID: NCT04136392

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2026-01-31

Brief Summary

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 devices

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Abiomed Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Almedhychy, MD

Role: STUDY_DIRECTOR

Abiomed Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Health Research Institute, Banner Good Samaritan Hospital

Phoenix, Arizona, United States

Banner University Medical Center

Tucson, Arizona, United States

University of Southern California Keck Hospital

Los Angeles, California, United States

Cedars Sinai

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

The Center for Advanced Research Excellence - Delray Medical Center

Delray Beach, Florida, United States

St. Vincent's Medical Center

Jacksonville, Florida, United States

Mercy Hospital Research Institute

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

University Cardiology Associates

Augusta, Georgia, United States

WellStar Research Institute

Marietta, Georgia, United States

University of Kansas Hospital

Kansas City, Kansas, United States

University of Louisville School of Medicine

Louisville, Kentucky, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

Ochsner Clinic Health Services Corporation

New Orleans, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital - Corrigan Minehan Heart Center

Boston, Massachusetts, United States

St. Vincent Hospital

Worcester, Massachusetts, United States

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

Detroit Medical Center

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Beaumont Health Center

Royal Oak, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Northwell Health

Manhasset, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Mercy Health Anderson

Cincinnati, Ohio, United States

University Hospital Cleveland Medical Center

Cleveland, Ohio, United States

Good Samaritan Hospital

Dayton, Ohio, United States

Mercy Health - Fairfield Hospital Research Center

Fairfield, Ohio, United States

Integris Cardiovascular Physicians

Oklahoma City, Oklahoma, United States

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute Inc.

Wormleysburg, Pennsylvania, United States

Jackson General Hospital

Jackson, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Heart and Vascular Institute

Dallas, Texas, United States

Plaza Medical Center of Fort Worth

Fort Worth, Texas, United States

Baylor College of Medicine - TX Heart Institute

Houston, Texas, United States

The University of Texas - Health Science Center & Medical School at Houston

Houston, Texas, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Carilion Medical Center

Roanoke, Virginia, United States

University of Washington

Seattle, Washington, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Countries

United States

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Other Identifiers

USPella

Identifier Type: OTHER

Identifier Source: secondary_id

The Global cVAD Registry

Identifier Type: OTHER

Identifier Source: secondary_id

cVAD

Identifier Type: -

Identifier Source: org_study_id