search
Back to results

Atrial Fibrillation Ablation

Primary Purpose

Atrial Fibrillation, Heart Failure, Diastolic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
trans cateheter ablation
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Raffaele Marfella

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

All patients affected by paroxysmal symptomatic atrial fibrillation, and anti-arrhythmic drug refractory atrial fibrillation will receive a trans catheter ablation therapy (intervention).

Outcomes

Primary Outcome Measures

Atrial Fibrillation (AF) recurrence
Authors will evaluate the percentage of patients in stable sinus rhythm after AF trans catheter ablation.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2017
Last Updated
January 25, 2018
Sponsor
University of Campania "Luigi Vanvitelli"
search

1. Study Identification

Unique Protocol Identification Number
NCT03410966
Brief Title
Atrial Fibrillation Ablation
Official Title
Paroxysmal Atrial Fibrillation Recurrences After Catheter Ablation: an Existing Correlation Between Oxidative Stress, Inflammation, Failing Heart Biomarkers and Atrial Fibrotic Remodeling.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure, Diastolic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
All patients affected by paroxysmal symptomatic atrial fibrillation, and anti-arrhythmic drug refractory atrial fibrillation will receive a trans catheter ablation therapy (intervention).
Intervention Type
Procedure
Intervention Name(s)
trans cateheter ablation
Other Intervention Name(s)
magnetic resonance of left atrium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Atrial Fibrillation (AF) recurrence
Description
Authors will evaluate the percentage of patients in stable sinus rhythm after AF trans catheter ablation.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celestino Sardu, MD, MSc, PhD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raffaele Marfella
City
Naples
ZIP/Postal Code
80128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
6 months

Learn more about this trial

Atrial Fibrillation Ablation

We'll reach out to this number within 24 hrs