Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes
Faizus Sazzad, Ying Kiat Tan, Li Xuan Beverly Chan, Irwan Shah Bin Mohd Moideen, Abdulrahman El Gohary, John C Stevens, K R Ramanathan, Theo Kofidis · 2023
Read Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes by Faizus Sazzad, Ying Kiat Tan, Li Xuan Beverly Chan, Irwan Shah Bin Mohd Moideen, Abdulrahman El Gohary, John C Stevens, K R Ramanathan, Theo Kofidis (2023) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-10688009.txt.
Description
Faizus Sazzad and seven co-authors published this systematic review in 2023. It examines first-in-human and early trials of surgically implanted biological mitral valve replacements. The authors found the reporting of trials inconsistent, and set out to build the case for uniform protocols.
Searching six databases up to March 2023, they screened over two thousand papers and kept twenty-two studies covering 3,332 patients. Valve sizes ran from twenty-one to thirty-seven millimeters, with twenty-nine the most common. First-in-human groups were small, about thirty-one patients, and their studies shorter than later cohorts. Follow-up length differed between study types. The authors argue that early reports carry lessons: how a novel implant performs, and what can go wrong, shapes development. They propose that standardized first-in-human reporting would help valve designers and regulators. Their data set the baseline for such a protocol.
Catalog record
| CREATOR | Faizus Sazzad, Ying Kiat Tan, Li Xuan Beverly Chan, Irwan Shah Bin Mohd Moideen, Abdulrahman El Gohary, John C Stevens, K R Ramanathan, Theo Kofidis |
|---|---|
| YEAR | 2023 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 33 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |