This "How caffeine Induces Atrial Tachyarrhythmias" trial will be a multi-center, randomized, double-blinded trial of intravenous caffeine versus placebo among patients undergoing pulmonary vein isolation procedures for Atrial Fibrillation(AF).
None
History of substance abuse or alcoholism.
Left ventricular ejection fraction <50%.
Liver dysfunction.
Pregnancy.
Parallel
Intravenous caffeine
Other interventionGroup assigned to receive caffeine will receive intravenous(IV) caffeine and sodium benzoate infusion starting at 250-500 mg. This method will use an automated algorithm that adjusts the flow of the infusion depending on the individual's sex and weight and then in a serial fashion in response to blood caffeine measurements. Serial blood caffeine measurements at pre-determined intervals according to the algorithm will be until a steady state is obtained.
Masked Placebo
Other interventionThe patients assigned to the masked placebo will receive 5% dextrose in 0.45% saline using the same infusion protocol for a random length of time that was within 1 standard deviation(SD) of the mean time to achieve a steady state using the caffeine protocol (17+4 min). To maintain blinding, caffeine blood concentration measurements that will be randomly generated within 2 SDs of the predicted values calculated by the algorithm will be used and verbally communicated for placebo infusions.
Number of Participants With Atrial Fibrillation Induction
Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.
Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period)
It helps assess changes in AERP in milli-seconds at different potential trigger points of Atrial fibrillation during the procedure.
Number of patients with Changes in conduction time
Changes in conduction time is the changes in conduction of electrical impulses with caffeine during the procedure.
Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias
By infusing caffeine, intraprocedural for stimulation and detection of potential triggers of ablation, will caffeine infusion lead to the start of atrial fibrillation (AF), atrial tachycardia(AT) or any other arrhythmias.
Number of patients with Identification of non-pulmonary triggers of AF
Identification of non-pulmonary triggers of AF
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Kansas City Heart Rhythm Research Foundation
Lead sponsor
Kansas City Heart Rhythm Institute
Collaborator
Texas Cardiac Arrhythmia Institute, Austin, TX, USA
Collaborator
Loma Linda University, Loma Linda, California, USA
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
