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

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Adenosine; Drug: Isoproterenol

• Registration Number: NCT03032965
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Results First Submitted: 2017-09-28
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Results First Posted: 2017-12-13
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adenosine and Isoproterenol	Isoproterenol	Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.
Isoproterenol	Isoproterenol	This group will not receive adenosine during the procedure.
Adenosine and Isoproterenol	Adenosine	Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Primary Outcome Measures

Name	Time	Method
Freedom From Any Atrial Arrhythmias	2- 14 months after Ablation procedure	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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Need Repeat Ablations	date of ablation to 6 months after procedure	Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.
Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups	post-procedure (6 months)	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.
Incidence of Pulmonary Vein Stenosis	6 months post-procedure	Number of subjects who develop Symptomatic pulmonary vein stenosis
Incidence of Atrio-esophageal Fistula	within 4 weeks	Number of subjects who develop connection between heart and the esophagus
Incidence of Stroke	peri-procedural (0 to 30 days after procedure)	Number of subjects who develop stroke within 30 days after procedure.
Incidence of Death	with 90 days of the procedure	Number of deaths within 90 days of the procedure.
Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation	first three months post ablation
Incidence of Cardiac Perforation	within 24 hours	Number of subjects who develop perforation of heart during ablation

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States