The Global cVAD Study
- Conditions
- Cardiovascular Diseases
- Interventions
- Device: ABIOMED, Inc. hemodynamic support devices
- Registration Number
- NCT04136392
- Lead Sponsor
- Abiomed Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- 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.
- Patients in whom an attempt to implant an ABIOMED, Inc. hemodynamic support device did not occur.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Eligible Patients ABIOMED, Inc. hemodynamic support devices 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.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events including Major Adverse Cardiac and Cerebrovascular Events 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
University Cardiology Associates
🇺🇸Augusta, Georgia, United States
St. Vincent Hospital
🇺🇸Worcester, Massachusetts, United States
University of Southern California Keck Hospital
🇺🇸Los Angeles, California, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
WellStar Research Institute
🇺🇸Marietta, Georgia, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
The Center for Advanced Research Excellence - Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Beaumont Health Center
🇺🇸Royal Oak, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Northwell Health
🇺🇸Manhasset, 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
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Mercy Health - Fairfield Hospital Research Center
🇺🇸Fairfield, Ohio, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute Inc.
🇺🇸Wormleysburg, Pennsylvania, United States
Baylor Heart and Vascular Institute
🇺🇸Dallas, Texas, United States
Plaza Medical Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospital Cleveland Medical Center
🇺🇸Cleveland, Ohio, 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
Mercy Hospital Research Institute
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
Jackson General Hospital
🇺🇸Jackson, Tennessee, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Massachusetts General Hospital - Corrigan Minehan Heart Center
🇺🇸Boston, Massachusetts, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Ochsner Clinic Health Services Corporation
🇺🇸New Orleans, Louisiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Banner Health Research Institute, Banner Good Samaritan Hospital
🇺🇸Phoenix, Arizona, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Orlando Health
🇺🇸Orlando, Florida, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
Integris Cardiovascular Physicians
🇺🇸Oklahoma City, Oklahoma, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Michigan Cardiovascular Center
🇺🇸Ann Arbor, Michigan, United States
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Mercy Health Anderson
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States