NCT04056832 - 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)

Coffey S, Cairns BJ, Iung B
The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. Review.
d'Arcy JL, Prendergast BD, Chambers JB, Ray SG, Bridgewater B
Valvular heart disease: the next cardiac epidemic. Heart. 2011 Jan;97(2):91-3. doi: 10.1136/hrt.2010.205096. Epub 2010 Dec 13. Erratum in: Heart. 2011 Jul;97(13):1112.
Maganti K, Rigolin VH, Sarano ME, Bonow RO
Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010 May;85(5):483-500. doi: 10.4065/mcp.2009.0706. Review.
Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP
Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling

Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study

Clinical trial NCT04056832 - References