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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02129842
• Lead Sponsor: Itamar-Medical, Israel

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-04-30
• Study Start: 2014-05
• Study First Posted: 2014-05-02
• Status Verified: 2014-12
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from AF/AFL/AT off antiarrhythmic drugs therapy	12 months

Secondary Outcome Measures

Name	Time	Method
Acute procedural success: Pulmonary veins isolation	12 months
75% reduction in the number/duration of AFib episodes	12 months

Trial Locations

Locations (6)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

University Heart Center Hamburg; 🇩🇪 Hamburg, Germany

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

New York University School of Medicine; 🇺🇸 NY, New York, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Royal Brompton & Harefield NHS Foundation Trust; 🇬🇧 London, United Kingdom