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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02129842
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):
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

Condition or disease
Atrial Fibrillation

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).

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : May 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Atrial Fibrillation

Primary Outcome Measures :
  1. Freedom from AF/AFL/AT off antiarrhythmic drugs therapy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
AFib patients eligible for ablation treatment

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02129842

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

Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1.

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Responsible Party: Itamar-Medical, Israel Identifier: NCT02129842     History of Changes
Other Study ID Numbers: Endo-AFib-001
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: December 2014

Keywords provided by Itamar-Medical, Israel:
Endothelial dysfunction

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes