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

Completed · Phase 2

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03032965

Run by

University of Michigan

People needed

131

Starts

2011-10-01

Expected to finish

2015-07-01

Last updated by the study team

2017-12-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients >18 and <75 who are able to give informed consent undergoing atrial fibrillation ablation procedure.
• Paroxysmal Atrial fibrillation lasting = 7 days which is self-terminating. It is considered recurrent if two or more episodes occur.
• Failure or unwilling to take class I or III anti-arrhythmic drugs

You may not qualify if…

• History of asthma
• Patients with severe coronary artery disease, stable/unstable angina, or ongoing myocardial ischemia
• Previous cardiac surgery ( excluding CABG and mitral valve surgery)
• Symptomatic congestive heart failure including but not limited to NYHA III/IV and/or documented ejection fraction <40% measured by acceptable cardiac testing,
• Left atrial diameter >55mm
• Moderate to severe mitral or aortic valve disease
• Myocardial infarction within three months of enrollment
• Congenital heart disease where it increases the risk of an ablative procedure
• Prior ASD/PFO closure with a device using a percutaneous approach
• Hypertrophic cardiomyopathy (LV wall thickness >1.5mm)
• Pulmonary Hypertension (mean or systolic PA pressure> 50mmHg on Doppler echocardiography
• Any prior ablation of atrial fibrillation
• Enrollment in any other arrhythmia protocol
• Any ventricular arrhythmia being treated where the arrhythmia or management may interfere with this study
• Active infection or sepsis
• Any history of cerebrovascular disease including stroke or TIAs
• Pregnancy or lactation
• Left atrial thrombus at the time of ablation
• Untreatable allergy to contrast media
• Any diagnosis of atrial fibrillation secondary to electrolyte disturbance, thyroid disease, or any other reversible or non-cardiovascular causes
• History of blood clotting(bleeding or thrombotic) abnormalities
• Known sensitivities to heparin or warfarin
• Severe COPD (defined as FEV1 <1)
• 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)

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.