NCT05097183 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Redondo A, Santos-Martínez S, Delgado-Arana R, Baladrón Zorita C, San Román JA, Amat-Santos IJ
Fluoroscopic-based algorithm for commissural alignment assessment after transcatheter aortic valve implantation. Rev Esp Cardiol (Engl Ed). 2022 Feb;75(2):184-187. doi: 10.1016/j.rec.2021.08.010. Epub 2021 Sep 30. English, Spanish.
Redondo A, Valencia-Serrano F, Santos-Martínez S, Delgado-Arana JR, Barrero A, Serrador A, Gutiérrez H, Sánchez-Lite I, Sevilla T, Revilla A, Baladrón C, Kim WK, Carrasco-Moraleja M, San Román JA, Amat-Santos IJ
Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept. Rev Esp Cardiol (Engl Ed). 2022 Mar;75(3):203-212. doi: 10.1016/j.rec.2021.02.004. Epub 2021 Mar 26. English, Spanish.

Clinical Validation and Prognostic Evaluation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

Clinical trial NCT05097183 - References