NCT03047343 - 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)

Brooks A, Geldenhuys A, Zuhlke L, Human P, Zilla P
Pulmonary artery banding: still a valuable option in developing countries? Eur J Cardiothorac Surg. 2012 Feb;41(2):272-6. doi: 10.1016/j.ejcts.2011.05.053. Epub 2011 Dec 12.
Horowitz MD, Culpepper WS 3rd, Williams LC 3rd, Sundgaard-Riise K, Ochsner JL
Pulmonary artery banding: analysis of a 25-year experience. Ann Thorac Surg. 1989 Sep;48(3):444-50.
Pinho P, Von Oppell UO, Brink J, Hewitson J
Pulmonary artery banding: adequacy and long-term outcome. Eur J Cardiothorac Surg. 1997 Jan;11(1):105-11.
Takayama H, Sekiguchi A, Chikada M, Noma M, Ishizawa A, Takamoto S
Mortality of pulmonary artery banding in the current era: recent mortality of PA banding. Ann Thorac Surg. 2002 Oct;74(4):1219-23; discussion 1223-4.
Valente AS, Mesquita F, Mejia JA, Maia IC, Maior MS, Branco KC, Pinto VC Jr, Carvalho W Jr
Pulmonary artery banding: a simple procedure? A critical analysis at a tertiary center. Rev Bras Cir Cardiovasc. 2009 Jul-Sep;24(3):327-33. English, Portuguese.
Yoshimura N, Yamaguchi M, Oka S, Yoshida M, Murakami H
Pulmonary artery banding still has an important role in the treatment of congenital heart disease. Ann Thorac Surg. 2005 Apr;79(4):1463; author reply 1463-4.

Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery

Clinical trial NCT03047343 - References