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

Completed

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT02129842

Run by

Itamar-Medical, Israel

People needed

150

Starts

2014-05-01

Expected to finish

2016-11-01

Last updated by the study team

2017-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• University Heart Center Hamburg — Hamburg, Germany
• Sheba Medical Center — Ramat Gan, Israel
• Royal Brompton & Harefield NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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