Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Adenosine; Isoproterenol
Intervention description: 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.
Intervention MeSH terms: Adenosine; Isoproterenol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: atrial fibrillation; ablation; adenosine

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients >18 and <75 who are able to give informed consent undergoing atrial
             fibrillation ablation procedure.

          2. Paroxysmal Atrial fibrillation lasting = 7 days which is self-terminating. It is
             considered recurrent if two or more episodes occur.

          3. Failure or unwilling to take class I or III anti-arrhythmic drugs

        Exclusion Criteria:

          1. History of asthma

          2. Patients with severe coronary artery disease, stable/unstable angina, or ongoing
             myocardial ischemia

          3. Previous cardiac surgery ( excluding CABG and mitral valve surgery)

          4. Symptomatic congestive heart failure including but not limited to NYHA III/IV and/or
             documented ejection fraction <40% measured by acceptable cardiac testing,

          5. Left atrial diameter >55mm

          6. Moderate to severe mitral or aortic valve disease

          7. Myocardial infarction within three months of enrollment

          8. Congenital heart disease where it increases the risk of an ablative procedure

          9. Prior ASD/PFO closure with a device using a percutaneous approach

         10. Hypertrophic cardiomyopathy (LV wall thickness >1.5mm)

         11. Pulmonary Hypertension (mean or systolic PA pressure> 50mmHg on Doppler
             echocardiography

         12. Any prior ablation of atrial fibrillation

         13. Enrollment in any other arrhythmia protocol

         14. Any ventricular arrhythmia being treated where the arrhythmia or management may
             interfere with this study

         15. Active infection or sepsis

         16. Any history of cerebrovascular disease including stroke or TIAs

         17. Pregnancy or lactation

         18. Left atrial thrombus at the time of ablation

         19. Untreatable allergy to contrast media

         20. Any diagnosis of atrial fibrillation secondary to electrolyte disturbance, thyroid
             disease, or any other reversible or non-cardiovascular causes

         21. History of blood clotting(bleeding or thrombotic) abnormalities

         22. Known sensitivities to heparin or warfarin

         23. Severe COPD (defined as FEV1 <1)

         24. Severe comorbidity or poor general physical/mental health that, in opinion of the
             investigator, will not allow the patient to be a good study candidate (i.e. other
             disease processes, mental capacity, substance abuse, shortened life expectancy)