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



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/10/2017
Start Date:May 2014
End Date:November 2016

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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

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

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).

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
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1428 Madison Ave
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(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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