NCT00208806 - 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)

Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group
Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.
Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators
Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.
Gras D, Leclercq C, Tang AS, Bucknall C, Luttikhuis HO, Kirstein-Pedersen A
Cardiac resynchronization therapy in advanced heart failure the multicenter InSync clinical study. Eur J Heart Fail. 2002 Jun;4(3):311-20.
Janousek J, Vojtovic P, Hucín B, Tláskal T, Gebauer RA, Gebauer R, Matejka T, Marek J, Reich O
Resynchronization pacing is a useful adjunct to the management of acute heart failure after surgery for congenital heart defects. Am J Cardiol. 2001 Jul 15;88(2):145-52.
Zimmerman FJ, Starr JP, Koenig PR, Smith P, Hijazi ZM, Bacha EA
Acute hemodynamic benefit of multisite ventricular pacing after congenital heart surgery. Ann Thorac Surg. 2003 Jun;75(6):1775-80.

Clinical Evaluation of Dilated Cardiomyopathy and Cardiac Resynchronization Therapy for Ventricular Dysfunction in Young Patients With and Without Congenital Heart Disease

Details for clinical trial NCT00208806

Clinical trial NCT00208806 - References