Atrial Fibrillation Ablation

NCT03410966 | Completed

• 1 other identifier: 2712.2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation (AF) recurrence

  Authors will evaluate the percentage of patients in stable sinus rhythm after AF trans catheter ablation.

  12 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

trans cateheter ablation PROCEDURE

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.

Also known as: magnetic resonance of left atrium

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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%).

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80128, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

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

Study Officials

• Celestino Sardu, MD, MSc, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 25, 2018
• Study Start: January 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months

Locations

IT (1)