NCT04091919 - 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)

Balci KG, Balci MM, Aksoy MM, Yilmaz S, Aytürk M, Dogan M, Yeter E, Akdemir R
Remodeling process in right and left ventricle after percutaneous atrial septal defect closure in adult patients. Turk Kardiyol Dern Ars. 2015 Apr;43(3):250-8. doi: 10.5543/tkd
Bussadori C, Oliveira P, Arcidiacono C, Saracino A, Nicolosi E, Negura D, Piazza L, Micheletti A, Chessa M, Butera G, Dua JS, Carminati M
Right and left ventricular strain and strain rate in young adults before and after percutaneous atrial septal defect
Lange A, Coleman DM, Palka P, Burstow DJ, Wilkinson JL, Godman MJ
Effect of catheter device closure of atrial septal defect on diastolic mitral annular motion. Am J Cardiol. 2003 Jan 1;91(1):104-8.
Wu ET, Akagi T, Taniguchi M, Maruo T, Sakuragi S, Otsuki S, Okamoto Y, Sano S
Differences in right and left ventricular remodeling after transcatheter closure of atrial septal defect among adults. Catheter Cardiovasc Interv. 2007 May 1;69(6):866-71.

Assessment of Left and Right Ventricular Strain and Strain Rate Before and After Percutaneous Closure of Atrial Septal Defects in Adults and Adolescents

Details for clinical trial NCT04091919

Clinical trial NCT04091919 - References