Radial Ablation for the Control of Persistent Atrial Fibrillation

N/AActive Not RecruitingNCT04662489

Fundacion para la Innovacion en Biomedicina (FIBMED)244 enrolled

Overview

The protocol aims to evaluate the efficacy of the radial ablation technique of the maintenance mechanisms in persistent atrial fibrillation compared to the isolation of the pulmonary veins evaluating the atrial fibrillation burden during one year follow-up.

Atrial fibrillation is the most common arrhythmia in clinical practice, and its treatment still remains suboptimal. Electrical isolation of the pulmonary veins with radiofrequency ablation or cryoablation is the standard therapy when antiarrhythmic drugs or electrical cardioversion is not successful. However, recurrence after catheter ablation worsens in persistent and permanent atrial fibrillation patients. Recently, rotational activity electrogram patterns of self-sustained electrical activity found in the atria have been proposed as the responsible mechanism for the maintenance of atrial fibrillation. The investigators devised a controlled, multicentric, prospective, not blinded, and randomized clinical trial with the aim of comparing pulmonary vein catheter ablation versus radial ablation of sites exhibiting rotational activity in patients with persistent atrial fibrillation. Radial ablation consists of the ablation of the rotational activity sites and an additional ablation line connecting the rotation site with the circumferential ablation line of the pulmonary veins. Besides, subanalysis ARTIST-Gender and ARTIST-HF will be performed. ARTIST-Gender will compare the same outcomes and analysis of the patient cohort but according to the gender of the patient, and ARTIST-HF will sub-divide the analysis with respect to heart failure present in the enrolled patients' cohort.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

244

Conditions

Persistent Atrial Fibrillation

Interventions

Pulmonary vein electrical isolationPROCEDURE

Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy

Radial ablationPROCEDURE

Electrical isolation of the pulmonary veins from the left atrium plus radial ablation of rotational activity sites with radiofrequency ablation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years and ≤ 75 years. * Non-valvular symptomatic persistent atrial fibrillation. * Patient willingness to participate in the study providing signed written informed consent. * Failure or drug intolerance or refusal to continue with chronic antiarrhythmic treatment. * Left ventricular ejection fraction LVEF) ≥ 25 % in the last echocardiogram prior to enrollment. Exclusion Criteria: * Left atrial diameter \> 5.5 cm in the last echocardiogram. * Contraindication of chronic anticoagulation or heparin. * Previous atrial fibrillation ablation procedure. * Acute coronary syndrome, cardiac surgery or acute cerebrovascular accident in two months prior to enrollement. * Previous diagnosis for hyperthyroidism or hypothyroidism. * Mental or physical illness that disables the patient to participate in the study. * Scheduled cardiac percutaneous or surgical intervention. * Non-controlled hypertension \> 160/100. * Terminal renal insufficiency or dialysis. * Functional class IV of the New York Heart Association (NYHA). * Moderate valvular disease or previous mitral prosthesis. * Previous hypertrophic heart disease. * Life expectancy less than 12 months. * Inclusion on the transplant list. * Participation in another study so as not to interfere with the results. * Previous atrioventricular block. * Pericardial effusion. * Pregnancy or childbearing age without contraceptive treatment.

Locations (3)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Outcomes

Primary Outcomes

Atrial fibrillation burden (1 year)

Atrial fibrillation burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial fibrillation episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Time frame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.

Atrial flutter burden (1 year)

Atrial flutter burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial flutter episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Time frame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.

Atrial tachycardia burden (1 year)

Atrial tachycardia burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial tachycardia episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Time frame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.

Secondary Outcomes

Occurrence of severe complication of the ablation procedure

Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports. One week post-procedural complications included. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Time frame: 2 years

Overall clinical procedure, radiofrequency and fluoroscopy durations

Total time registered during the clinical procedure. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Time frame: 2 years

Data from ClinicalTrials.gov

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