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

March 8, 2017 updated by: Itamar-Medical, Israel

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Heart Center Hamburg
  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton & Harefield NHS Foundation Trust
  • United States
    • New York
      • NY, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Texas
      • Austin, Texas, United States, 78075
        • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

AFib patients eligible for ablation treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from AF/AFL/AT off antiarrhythmic drugs therapy
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Itamar-Medical, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endo-AFib-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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