Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
Study NCT ID:
NCT04136392
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-05-10
First Post:
2019-10-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Global cVAD Study
Sponsor:
Abiomed Inc.
Organization:
Study Overview
Official Title:
The Global cVAD Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
cVAD
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: