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OpenTrials
Completed

NCT Number: NCT02129842

Is Endothelial Function a Predictor of Successful Ablation Therapy Provided to 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heart Center Hamburg, Hamburg, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Freedom from AF/AFL/AT off antiarrhythmic drugs therapy

    Time frame: 12 months

Secondary outcomes

  1. Acute procedural success: Pulmonary veins isolation

    Time frame: 12 months

  2. 75% reduction in the number/duration of AFib episodes

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Itamar-Medical, Israel

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 2, 2014
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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