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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Itamar-Medical, Israel
Sponsor:
Information provided by (Responsible Party):
Itamar-Medical, Israel
ClinicalTrials.gov Identifier:
NCT02129842
First received: April 30, 2014
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Itamar-Medical, Israel:

Primary Outcome Measures:
  • Freedom from AF/AFL/AT off antiarrhythmic drugs therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute procedural success: Pulmonary veins isolation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 75% reduction in the number/duration of AFib episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

AFib patients eligible for ablation treatment

Criteria

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)
  • Hypo or hyperthyroidism
  • Hypertrophic myocardiopathy
  • Moderate or severe mitral valve disease or mitral prosthetic valve
  • Ejection fraction less than 30%
  • Left atrial anteroposterior diameter more than 50 mm.
  • Previous atrial fibrillation ablation occurred less than 6 months prior
  • Left atrium thrombus
  • Acute infective disease or sepsis in the last 3 months
  • Pregnant women
  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129842

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Betsy A Ellsworth, MSN, ANP    212-824-8902    betsy.ellsworth@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
New York University School of Medicine Recruiting
NY, New York, United States, 10016
Contact: Laura Kuznekoff    212-263-7704    Laura.Kuznekoff@nyumc.org   
Principal Investigator: Larry Chinitz, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78075
Contact: Deb Cardinal, RN    512-458-9410    dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, MD         
Germany
University Heart Center Hamburg Not yet recruiting
Hamburg, Germany, 20246
Contact: Kathrin Heitmann    +49 (0)40 7410-59471    k.heitmann@uke.de   
Principal Investigator: Stephan Willems, MD         
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Roy Beinart, MD    972-3-530-5330    Roy.Beinart@sheba.health.gov.il   
Principal Investigator: Michael Glikson, MD         
United Kingdom
Royal Brompton & Harefield NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Ginette Hoare, Dr    020 7351 8572    G.Hoare@rbht.nhs.uk   
Principal Investigator: Sabine Ernst, MD         
Sponsors and Collaborators
Itamar-Medical, Israel
  More Information

Publications:
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.

Responsible Party: Itamar-Medical, Israel
ClinicalTrials.gov Identifier: NCT02129842     History of Changes
Other Study ID Numbers: Endo-AFib-001
Study First Received: April 30, 2014
Last Updated: August 31, 2014
Health Authority: Israel: Ethics Commission
Germany: Ethics Commission
United Kingdom: Department of Health
United States: Institutional Review Board

Keywords provided by Itamar-Medical, Israel:
AFib
AF
ablation
EndoPAT
Endothelial dysfunction
PAT

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

ClinicalTrials.gov processed this record on September 14, 2014