Is Endothelial Function a Predictor of Successful Ablation Therapy Provided to Patients With Atrial Fibrillation?

Study Overview
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Brief Summary
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The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm following ablation

Detailed Description
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In the recent years, increasing evidence is linking inflammation to AFib. In addition, it has been shown that ablation improves endothelial function, suggesting that AFib might be associated with the etiology of endothelial dysfunction. The objective of this study is to assess endothelial function using Endo-PAT2000 and its correlation to clinical outcome following ablation of patients with Atrial Fibrillation (AFib).

Official Title
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A Prospective, Non-randomized, Double Blind Multicenter Study to Assess Endothelial Function Using Endo-PAT2000 and Its Correlation to Clinical Outcome Following Ablation in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with AF considered eligible for ablation treatment may be included in this study (following unsuccessful attempts with AAD). Patients on optimal anticoagulation therapy The minimum AF documentation required as defined by the Heart Rhythm Society Exclusion Criteria: Patients age below 18 years Cases with extremely abnormal anatomy (i.e., inverted heart) Moderate or severe mitral valve disease or mitral prosthetic valve Ejection fraction less than 30% Left atrial anteroposterior diameter more than 50 mm evaluated by echo or CT data (up to 6 months old).. Previous atrial fibrillation ablation occurred less than 6 months prior Left atrium thrombus Acute infective disease or sepsis in the last 3 months Acute myocardial infarction in last 3 months Reduced expectancy of life (less than 12 months) Patient participating in another clinical study that investigates a drug or device unless prior approval is given by the sponsor Psychologically unstable patient or denies to give informed consent Deformities of the digits of the upper extremities, which preclude adequate signal acquisition Patients under the effect of short-acting Nitroglycerin (3 hours washout period) Patient suffering from a medical condition prohibiting blood flow occlusion in both arms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial Fibrillation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from AF/AFL/AT off antiarrhythmic drugs therapy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedural success: Pulmonary veins isolation |  | 12 months | 
| 75% reduction in the number/duration of AFib episodes |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AFib, AF, ablation, EndoPAT, Endothelial dysfunction, PAT