The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial fibrillation thus decreasing the need for additional ablation procedures.
Hypothesis: 1. Adenosine reveals incomplete conduction block due to partial tissue injury/stunning during catheter ablation of atrial fibrillation. 2. Identification of incomplete conduction block by adenosine improves clinical outcomes including an increase in efficacy and a decrease in need for repeat procedures after catheter ablation of atrial fibrillation. Objectives: 1. In patients with paroxysmal Atrial Fibrillation (AF), the prevalence of Pulmonary Vein (PV) reconnection during adenosine infusion after complete PV isolation using conventional techniques will be determined. 2. Patients will be randomized to further ablation to achieve complete isolation during adenosine infusion vs to no further ablation. 3. Primary endpoint of the study will be freedom from any atrial arrhythmias 6 months after a single ablation procedure in the absence of antiarrhythmic drug therapy. 4. Secondary endpoints will include number of repeat ablation procedures because of documented recurrence of symptomatic AF or atrial flutter/tachycardia, outcome after 2 ablation procedures; Proportion of patients with AF or atrial flutter/tachycardia occuring during the first three months post ablation, prevalence of recovery of conduction into PVs during repeat ablation procedures in both groups, procedure duration, and incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, atrio-esophageal fistulae, and death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction. Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.
Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to\<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.
University of Michigan
Ann Arbor, Michigan, United States
Freedom From Any Atrial Arrhythmias
Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy
Time frame: 2- 14 months after Ablation procedure
Number of Subjects Who Need Repeat Ablations
Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.
Time frame: date of ablation to 6 months after procedure
Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation
Time frame: first three months post ablation
Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups
Prevalence of recovery of conduction into pulmonary veins during repeat ablation procedures in both groups. This is determined by surgeon assessment using a circular mapping catheter to identify recovery of conduction into the pulmonary veins.
Time frame: post-procedure (6 months)
Incidence of Stroke
Number of subjects who develop stroke within 30 days after procedure.
Time frame: peri-procedural (0 to 30 days after procedure)
Incidence of Pulmonary Vein Stenosis
Number of subjects who develop Symptomatic pulmonary vein stenosis
Time frame: 6 months post-procedure
Incidence of Cardiac Perforation
Number of subjects who develop perforation of heart during ablation
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Time frame: within 24 hours
Incidence of Atrio-esophageal Fistula
Number of subjects who develop connection between heart and the esophagus
Time frame: within 4 weeks
Incidence of Death
Number of deaths within 90 days of the procedure.
Time frame: with 90 days of the procedure