NCT04152967 - 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)

Dallaire F, Wald RM, Marelli A
The Role of Cardiopulmonary Exercise Testing for Decision Making in Patients with Repaired Tetralogy of Fallot. Pediatr Cardiol. 2017 Aug;38(6):1097-1105. doi: 10.1007/s00246-017-1656-z. Epub 2017 Jun 16. Review.
Hoashi T, Iwasa T, Kagisaki K, Shimada M, Kurosaki K, Shiraishi I, Ichikawa H
Long-term respiratory outcomes after primary total correction for tetralogy of Fallot and absent pulmonary valve in patient with respiratory symptoms. Congenit Heart Dis. 2017 Jul;12(4):441-447. doi: 10.1111/chd.12477. Epub 2017 May 19.
Reineke DC, Kaya A, Heinisch PP, Oezdemir B, Winkler B, Huber C, Heijmen RH, Morshuis W, Carrel TP, Englberger L
Long-term follow-up after implantation of the Shelhigh® No-React® complete biological aortic valved conduit. Eur J Cardiothorac Surg. 2016 Jul;50(1):98-104. doi: 10.1093/ejcts/ezv452. Epub 2015 Dec 30.
Schneider AW, Putter H, Klautz RJM, Bruggemans EF, Holman ER, Bökenkamp R, Hazekamp MG
Long-Term Follow-Up After the Ross Procedure: A Single Center 22-Year Experience. Ann Thorac Surg. 2017 Jun;103(6):1976-1983. doi: 10.1016/j.athoracsur.2016.11.064. Epub 2017 Feb 24.
van den Berg J, de Bie S, Meijboom FJ, Hop WC, Pattynama PM, Bogers AJ, Helbing WA
Changes during exercise of ECG intervals related to increased risk for ventricular arrhythmia in repaired tetralogy of Fallot and their relationship to right ventricular size and function. Int J Cardiol. 2008 Mar 14;124(3):332-8. Epub 2007 Apr 11.

New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract: A Multi-centre Clinical Research

Clinical trial NCT04152967 - References