Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Adenosine; Isoproterenol

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)