The Global cVAD Study (cVAD)
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|ClinicalTrials.gov Identifier: NCT04136392|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : May 10, 2021
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|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases||Device: ABIOMED, Inc. hemodynamic support devices|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||20000 participants|
|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|
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.
- 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.
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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|
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.
1. Patients in whom an attempt to implant an ABIOMED, Inc. hemodynamic support device did not occur.
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
|Study Director:||Ali Almedhychy, MD||Abiomed Inc.|
|Responsible Party:||Abiomed Inc.|
|Other Study ID Numbers:||
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|
|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|