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.
Who can participate
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.
Locations
13
Australia (1)
Perth Institute of Vascular Research
Nedlands , WAUS
Belgium (1)
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst , Eflndrs
China (1)
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , Shaanxi
France (1)
CH Chartres
Chartres , Centre-Val de Loire
Germany (1)
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main , Hesse
Hungary (1)
Semmelweis University
Budapest , Budapest
Italy (1)
Ospedale San Raffaele
Milan , Lombard
COMPLETED
Netherlands (1)
St. Antonius Ziekenhuis
Nieuwegein , Utrecht
COMPLETED
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona , Catalon
Switzerland (1)
Kantonsspital Aarau
Aarau , Basel
Taiwan (1)
Taichung Veterans General Hospital
Taichung , Mtaiwan
United Arab Emirates (1)
Al Qassimi Hospital
Sharjah city , Emirate of Sharjah
United States (1)
University Hospital - Univ. of Alabama at Birmingham (UAB)