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

NCT02129842 | Completed

• 1 other identifier: Endo-AFib-001
• Study Type: observational
• Target: 150
• Locations: 4 countries
• Sites: 6

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

Conditions

Atrial Fibrillation

Keywords

AFib; AF; ablation; EndoPAT; Endothelial dysfunction; PAT

Outcome Measures

Primary Outcomes (1)

• Freedom from AF/AFL/AT off antiarrhythmic drugs therapy

  12 months

Secondary Outcomes (2)

• Acute procedural success: Pulmonary veins isolation

  12 months

• 75% reduction in the number/duration of AFib episodes

  12 months

Study Arms (1)

Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AFib patients eligible for ablation treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Itamar-Medical, Israel: lead

Study Sites (6)

New York University School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78075, United States

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Location

Related Publications (5)

• 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. No abstract available.

  PMID: 22389422 BACKGROUND

• Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-147. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3.

  PMID: 23563126 BACKGROUND

• Pokushalov E, Romanov A, Artyomenko S, Turov A, Shugayev P, Shirokova N, Katritsis DG. Ganglionated plexi ablation for longstanding persistent atrial fibrillation. Europace. 2010 Mar;12(3):342-6. doi: 10.1093/europace/euq014.

  PMID: 20173210 BACKGROUND

• Boos CJ, Anderson RA, Lip GY. Is atrial fibrillation an inflammatory disorder? Eur Heart J. 2006 Jan;27(2):136-49. doi: 10.1093/eurheartj/ehi645. Epub 2005 Nov 8.

  PMID: 16278230 BACKGROUND

• Yoshino S, Yoshikawa A, Hamasaki S, Ishida S, Oketani N, Saihara K, Okui H, Kuwahata S, Fujita S, Ichiki H, Ueya N, Iriki Y, Maenosono R, Miyata M, Tei C. Atrial fibrillation-induced endothelial dysfunction improves after restoration of sinus rhythm. Int J Cardiol. 2013 Sep 30;168(2):1280-5. doi: 10.1016/j.ijcard.2012.12.006. Epub 2012 Dec 24.

  PMID: 23269316 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2014-12

Locations

US (3); GB (1); IL (1); DE (1)