NCT04659655 - 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)

Johnson CA Jr, Melvin AL, Lebow BF, Yap A, Knight PA
Video assisted right mini-thoracotomy for aortic valve replacement. J Vis Surg. 2018 Feb 27;4:39. doi: 10.21037/jovs.2018.01.16. eCollection 2018.
Nellis JR, Fitch ZW, Choi AY, Meza JM, Spector ZZ, Von Bergen NH, Torres JE, Klapper JA, Sauer JS, Turek JW
A Minimally Invasive Approach for Placing Sew-On Epicardial Leads in the Child. Innovations (Phila). 2018 Nov/Dec;13(6):455-457. doi: 10.1097/IMI.0000000000000568.
Robinson DA, Sagebin F, Yap AJ, Johnson CA Jr, Knight PA
Aortic valve replacement with annular enlargement via a right anterior minithoracotomy. Multimed Man Cardiothorac Surg. 2018 Jul 26;2018. doi: 10.1510/mmcts.2018.044.
Wong JK, Melvin AL, Siordia JA, Joshi DJ, Sauer JS, Knight PA
Novel Automated Suturing Technology for Minimally Invasive Aortic Valve Replacements. Ann Thorac Surg. 2018 Feb;105(2):645-649. doi: 10.1016/j.athoracsur.2017.07.054. Epub 2017 Nov 27.

VIenna Pilot Study for Automated Annular Suturing Technology to Assist in Aortic & Mitral Valve Replacement - A Single-center Clinical Safety & Feasibility Pilot Trial

Details for clinical trial NCT04659655

Clinical trial NCT04659655 - References