NCT04573660 Abbott Vascular Medical Device Registry
| NCT ID | NCT04573660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Acute Myocardial Infarction |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,784 participants |
| Start Date | 2020-10-25 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,784 participants in total. It began in 2020-10-25 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
Eligibility Criteria
Inclusion Criteria: 1. Subject is at least 18 years of age. 2. Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry. 3. Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol. 4. Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent. Exclusion Criteria: 1\. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.
Contact & Investigator
Chananit Hutson, PhD
STUDY DIRECTOR
Abbott Medical Devices
Frequently Asked Questions
Who can join the NCT04573660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04573660 currently recruiting?
Yes, NCT04573660 is actively recruiting participants. Contact the research team at sharanjeet.dhanjal@abbott.com for enrollment information.
Where is the NCT04573660 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Los Angeles, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT04573660 clinical trial?
NCT04573660 is sponsored by Abbott Medical Devices. The principal investigator is Chananit Hutson, PhD at Abbott Medical Devices. The trial plans to enroll 3,784 participants.