This trial is active, not recruiting.

Condition atrial fibrillation
Sponsor Itamar-Medical, Israel
Start date May 2014
End date December 2016
Trial size 150 participants
Trial identifier NCT02129842, Endo-AFib-001


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Freedom from AF/AFL/AT off antiarrhythmic drugs therapy
time frame: 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Itamar-Medical, Israel.