NCT03732742 - 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)

Kwak JG, Kim WH, Kim ER, Lim JH, Min J
One-Year Follow-up After Tetralogy of Fallot Total Repair Preserving Pulmonary Valve and Avoiding Right Ventriculotomy. Circ J. 2018 Oct 5. doi: 10.1253/circj.CJ-18-0690. [Epub ahead of print]
Vida VL, Angelini A, Guariento A, Frescura C, Fedrigo M, Padalino M, Sanders SP, Thiene G, Stellin G
Preserving the pulmonary valve during early repair of tetralogy of Fallot: Anatomic substrates and surgical strategies. J Thorac Cardiovasc Surg. 2015 May;149(5):1358-63.e1. doi: 10.1016/j.jtcvs.2015.01.030. Epub 2015 Jan 21.

Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching

Clinical trial NCT03732742 - References