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

Atrial Fibrillation Clinical Trial

Official title:

Adenosine Study in Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032965
• Other study ID #: HUM00048922
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2016
• Last updated: November 15, 2017
• Start date: October 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2- 14 months after Ablation procedure
Secondary	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.	date of ablation to 6 months after procedure
Secondary	Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation		first three months post ablation
Secondary	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.	post-procedure (6 months)
Secondary	Incidence of Stroke	Number of subjects who develop stroke within 30 days after procedure.	peri-procedural (0 to 30 days after procedure)
Secondary	Incidence of Pulmonary Vein Stenosis	Number of subjects who develop Symptomatic pulmonary vein stenosis	6 months post-procedure
Secondary	Incidence of Cardiac Perforation	Number of subjects who develop perforation of heart during ablation	within 24 hours
Secondary	Incidence of Atrio-esophageal Fistula	Number of subjects who develop connection between heart and the esophagus	within 4 weeks
Secondary	Incidence of Death	Number of deaths within 90 days of the procedure.	with 90 days of the procedure