Radial Ablation for the Control of Persistent Atrial Fibrillation

NCT ID: NCT04662489

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control arm. Pulmonary vein isolation

Pulmonary vein isolation with ablation.

Group Type: ACTIVE_COMPARATOR

Pulmonary vein electrical isolation

Intervention Type: PROCEDURE

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

Treatment arm. Radial ablation

Pulmonary vein isolation plus radial ablation of rotational activity sites.

Group Type: EXPERIMENTAL

Radial ablation

Intervention Type: PROCEDURE

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

Interventions

Pulmonary vein electrical isolation

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

Intervention Type: PROCEDURE

Radial ablation

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

Intervention Type: PROCEDURE

Other Intervention Names

Pulmonary veins ablation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role: collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role: collaborator

Fundacion para la Innovacion en Biomedicina (FIBMED)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angel Arenal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañón

Locations

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Countries

Spain

Other Identifiers

ARTIST

Identifier Type: -

Identifier Source: org_study_id