Clinical trial NCT01008722: The Dynamics of Human Atrial Fibrillation
Official title: The Dynamics of Human Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Tachyarrhythmia
Keywords: Atrial Fibrillation
Ablation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-11-06
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be men and women of all races aged 21 to 80 years undergoing clinically indicated ablation of Atrial Fibrillation.

Brief summary: The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.


Eligibility criteria: Inclusion Criteria:

* Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed \>or= 1 anti-arrhythmic drug.

Primary outcomes:
measure: Survival Free of Atrial Fibrillation
timeFrame: 6 -12 months
Secondary outcomes:
measure: Termination or Slowing of Atrial Fibrillation During Ablation
timeFrame: acute
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: VA San Diego Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Sanjiv M. Narayan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Narayan SM, Krummen DE, Rappel WJ. Clinical mapping approach to diagnose electrical rotors and focal impulse sources for human atrial fibrillation. J Cardiovasc Electrophysiol. 2012 May;23(5):447-54. doi: 10.1111/j.1540-8167.2012.02332.x. Epub 2012 Apr 26.
citation: Narayan SM, Patel J, Mulpuru S, Krummen DE. Focal impulse and rotor modulation ablation of sustaining rotors abruptly terminates persistent atrial fibrillation to sinus rhythm with elimination on follow-up: a video case study. Heart Rhythm. 2012 Sep;9(9):1436-9. doi: 10.1016/j.hrthm.2012.03.055. Epub 2012 Mar 28. No abstract available.
citation: Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-147. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3.
citation: Narayan SM, Shivkumar K, Krummen DE, Miller JM, Rappel WJ. Panoramic electrophysiological mapping but not electrogram morphology identifies stable sources for human atrial fibrillation: stable atrial fibrillation rotors and focal sources relate poorly to fractionated electrograms. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):58-67. doi: 10.1161/CIRCEP.111.977264. Epub 2013 Feb 7.
citation: 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.