NCT01237743 - 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)

Dittrich R, Ringelstein EB
Occurrence and clinical impact of microembolic signals during or after cardiosurgical procedures. Stroke. 2008 Feb;39(2):503-11. doi: 10.1161/STROKEAHA.107.491241. Epub 2008 Jan 3. Review.
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators
Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
Lund C, Nes RB, Ugelstad TP, Due-Tønnessen P, Andersen R, Hol PK, Brucher R, Russell D
Cerebral emboli during left heart catheterization may cause acute brain injury. Eur Heart J. 2005 Jul;26(13):1269-75. Epub 2005 Feb 16.
Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV
Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007 Aug 14;116(7):755-63. Epub 2007 Jul 23.

Transcranial Doppler Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation

Clinical trial NCT01237743 - References