Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

Paroxysmal Atrial Fibrillation Recurrences After Catheter Ablation: an Existing Correlation Between Oxidative Stress, Inflammation, Failing Heart Biomarkers and Atrial Fibrotic Remodeling.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410966
• Other study ID #: 2712.2017
• Status: Completed
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 25, 2018
• Start date: January 1, 2013
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2018
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective. Atrial fibrillation (AF) recurrence after catheter ablation (CA) is a relevant clinical problem.

Methods. 123 patients with paroxysmal AF will be identified and screened for participation in this randomized, prospective, double blind, controlled placebo multicenter trial. 109 patients will be randomly assigned and enrolled in the study trial. Enrolled patients will receive magnetic atrial resonance and then will be treated by CA to receive pulmonary vein isolation (PVI). In this patients cytokines, inflammatory markers, and biomarkers such as ST2 protein and B type natriuretic peptide (BNP) will be evaluated at baseline, after CA, and during follow up. These biomarkers will be correlated to clinical outcomes (AF recurrences and heart failure progression and hospitalizations), and to fibrotic atrium extension as evaluated by magnetic resonance.

Description:

Catheter ablation (CA) is first class treatment to restore sinus rhythm in patients with paroxysmal, symptomatic, drug refractory atrial fibrillation (AF). The sinus rhythm restoration after a successful CA may improve symptoms, New York Heart Association (NYHA) class and quality of life, reducing thromboembolic complications, and the likely progression of the arrhythmic disease towards forms of heart failure. Conversely, patients that do not respond successfully to CA therapy may still have AF, that is linked to an increased risk of ischemic stroke, heart failure, and overall mortality. AF recurrence after CA occurs in a percentage of patients ranging from 20% to 60%. This high rate of therapeutic failure, and the higher number of patients suffering for paroxysmal AF, represent a not acceptable problem in the clinical practice. The causes to explain this therapeutic failure are not completely clear, and broadly investigated by authors. To date, hyper activity of inflammatory tone, and oxidative stress with secondary left atrium enlargement and fibrosis, may represent a crucial part of molecular, and cellular adaptive processes linked to electro-anatomical remodeling, and to the AF perpetuation after an ablative treatment. Intriguingly, if the atrial fibrosis extension is a known process linked to worse prognosis, conversely the ablative approach therapy by burning to destroy arrhythmic cells, may also induce inflammation and atrial fibrotic lines around the veins' ostia. Therefore, the double face of the coin shows to the investigators the atrial fibrosis as an adaptive remodeling process linked to worse prognosis, and the atrial fibrosis as the result of a correct ablative approach to isolate pulmonary veins ostia and to improve clinical outcomes. To simply the concept, authors have to consider the first as an adaptive process leading to worse prognosis in AF patients, and the second as a necessary treatment to improve clinical outcomes in AF patients. Different studies have investigated cytokines, inflammatory markers, and other peptides such as B type natriuretic peptide (BNP), before and after CA in paroxysmal AF patients. These markers, and particularly BNP are correlated to atrial fibrosis extension, and worse prognosis after an ablative approach, and to the progression towards failing heart disease. Recently, the ST2 protein has been proposed as a new marker of heart fibrosis, such as a predictor of heart failure. Currently, no data has been reported about ST2 protein and AF recurrences after an ablative approach. Moreover, in the current study authors will investigate at baseline, and at follow up after an ablative approach, the using of cytokines, inflammatory markers, and other peptides such as B type natriuretic peptide (BNP), and ST2 protein, regards to these adaptive atrial fibrotic processes, and to AF recurrences after catheter ablation. Therefore, in this study authors will evaluate these biomarkers in patients with symptomatic and drug refractory paroxysmal AF undergoing catheter ablation interventions, and their correlation to AF recurrence rate after catheter ablation. To date, in the present study authors will correlate these biomarkers, and particularly ST2 protein to AF recurrences after CA, to left atrium fibrotic remodeling, and to hospitalizations events for heart failure at 12 months follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• aged more than 18,

• aged less than 75;

• clinical diagnosis of paroxysmal atrial fibrillation (AF)

• clinical diagnosis of symptomatic and anty- arrhythmic drugs refractory (AF)

• echocardiographic diagnosis of normal left atrium volumetry (left atrium volume < 30 ml/mq)

• echocardiographic diagnosis of normal left ventricle ejection fraction (LVEF) (LVEF > 55%).

Exclusion Criteria:

• aged less than 18,

• aged more than 75;

• clinical diagnosis of not paroxysmal AF;

• clinical diagnosis of heart failure;

• echocardiographic diagnosis of left atrium dilatation (left atrium volume > 30 ml/mq);

• echocardiographic diagnosis of LVEF depression (LVEF <55%).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Heart Failure, Diastolic

Intervention

Procedure:
• trans cateheter ablation
All AF patients will receive trans catheter ablation by radiofrequency, to destroy arrhythmic atrial cells, and to isolate arrhythmic atrial firing around pulmonary veins' ostia.

Locations

Country	Name	City	State
Italy	Raffaele Marfella	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation (AF) recurrence	Authors will evaluate the percentage of patients in stable sinus rhythm after AF trans catheter ablation.	12 months