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

NCT ID: NCT03032965

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-07-31

Brief 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.

Detailed Description

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ablation; adenosine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adenosine and Isoproterenol

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Group Type: EXPERIMENTAL

Adenosine

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Isoproterenol

This group will not receive adenosine during the procedure.

Group Type: OTHER

Isoproterenol

Intervention Type: DRUG

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.

Interventions

Adenosine

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.

Intervention Type: DRUG

Isoproterenol

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 Type: DRUG

Other Intervention Names

Isuprel

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hamid Ghanbari

Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamid Ghanbari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00048922

Identifier Type: -

Identifier Source: org_study_id