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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-11-30

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

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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).

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial Fibrillation

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No