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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129842
• Other study ID #: Endo-AFib-001
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: March 8, 2017
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2014
• Source: Itamar-Medical, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	University Heart Center Hamburg	Hamburg
Israel	Sheba Medical Center	Ramat Gan
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	London
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York University School of Medicine	NY	New York

Sponsors (1)

Lead Sponsor	Collaborator
Itamar-Medical, Israel

Countries where clinical trial is conducted

United States,  Germany,  Israel,  United Kingdom, 

References & Publications (5)

Boos CJ, Anderson RA, Lip GY. Is atrial fibrillation an inflammatory disorder? Eur Heart J. 2006 Jan;27(2):136-49. Review. — View Citation

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. — View Citation

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):138-47. doi: 10.1016/j.jacc.2013.03.021. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from AF/AFL/AT off antiarrhythmic drugs therapy		12 months
Secondary	Acute procedural success: Pulmonary veins isolation		12 months
Secondary	75% reduction in the number/duration of AFib episodes		12 months