Persistent Atrial Fibrillation — The Substrate and Intervention Mechanisms for Persistent Atrial Fibrillation Trial
Citation(s)
Akoum N, Marrouche N Assessment and impact of cardiac fibrosis on atrial fibrillation. Curr Cardiol Rep. 2014 Aug;16(8):518. doi: 10.1007/s11886-014-0518-z. Review.
Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13.
Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
Runge VM Safety of magnetic resonance contrast media. Top Magn Reson Imaging. 2001 Aug;12(4):309-14. Review.
Schenck JF Safety of strong, static magnetic fields. J Magn Reson Imaging. 2000 Jul;12(1):2-19. Review.
Shivkumar K, Ellenbogen KA, Hummel JD, Miller JM, Steinberg JS Acute termination of human atrial fibrillation by identification and catheter ablation of localized rotors and sources: first multicenter experience of focal impulse and rotor modulation (FIRM) ablation. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1277-85. doi: 10.1111/jce.12000. Epub 2012 Nov 6.
Wilber DJ Fibroblasts, focal triggers, and persistent atrial fibrillation: is there a connection? Circ Arrhythm Electrophysiol. 2012 Apr;5(2):249-51. doi: 10.1161/CIRCEP.111.968750.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.