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Atrial Fibrillation Ablation

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ClinicalTrials.gov Identifier: NCT03410966
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

Brief 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Heart Failure, Diastolic Procedure: trans cateheter ablation Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Paroxysmal Atrial Fibrillation Recurrences After Catheter Ablation: an Existing Correlation Between Oxidative Stress, Inflammation, Failing Heart Biomarkers and Atrial Fibrotic Remodeling.
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention group
All patients affected by paroxysmal symptomatic atrial fibrillation, and anti-arrhythmic drug refractory atrial fibrillation will receive a trans catheter ablation therapy (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.
Other Name: magnetic resonance of left atrium



Primary Outcome Measures :
  1. Atrial Fibrillation (AF) recurrence [ Time Frame: 12 months ]
    Authors will evaluate the percentage of patients in stable sinus rhythm after AF trans catheter ablation.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%).

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 ClinicalTrials.gov identifier (NCT number): NCT03410966


Locations
Italy
Raffaele Marfella
Naples, Italy, 80128
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Principal Investigator: Celestino Sardu, MD, MSc, PhD University of Campania "Luigi Vanvitelli"

Responsible Party: Celestino Sardu, Clinical Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03410966     History of Changes
Other Study ID Numbers: 2712.2017
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: 6 months
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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