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The Global cVAD Study (cVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04136392
Recruitment Status : Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : May 10, 2021
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Yale University
Information provided by (Responsible Party):
Abiomed Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Device: ABIOMED, Inc. hemodynamic support devices

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Global cVAD Study
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026
Groups and Cohorts
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136392


Locations
Show Show 51 study locations
Sponsors and Collaborators
Abiomed Inc.
Beth Israel Deaconess Medical Center
Yale University
Investigators
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Study Director: Ali Almedhychy, MD Abiomed Inc.
More Information
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Publications:

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Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT04136392    
Other Study ID Numbers: cVAD
USPella ( Other Identifier: Abiomed, Inc. )
The Global cVAD Registry ( Other Identifier: Abiomed, Inc. )
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cardiovascular Diseases