Radial Ablation for the Control of Persistent Atrial Fibrillation

NCT04662489 | Active Not Recruiting DMC

• 1 other identifier: ARTIST
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 3

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.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter ablation; Radial ablation; Rotors

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (10)

• Occurrence of severe complication of the ablation procedure

  2 years

• Overall clinical procedure, radiofrequency and fluoroscopy durations

  2 years

• Accute procedural success rate

  2 years

• Occurrence of hospitalization for cardiovascular cause

  1 year

• Cerebrovascular accident unforeseen hospitalization

  1 year

Study Arms (2)

Control arm. Pulmonary vein isolation

ACTIVE COMPARATOR

Pulmonary vein isolation with ablation.

Procedure: Pulmonary vein electrical isolation

Treatment arm. Radial ablation

EXPERIMENTAL

Pulmonary vein isolation plus radial ablation of rotational activity sites.

Procedure: Radial ablation

Interventions

Pulmonary vein electrical isolation PROCEDURE

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

Also known as: Pulmonary veins ablation

Control arm. Pulmonary vein isolation

Radial ablation PROCEDURE

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

Treatment arm. Radial ablation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in another study so as not to interfere with the results.
• Previous atrioventricular block.

Sponsors & Collaborators

• Fundacion para la Innovacion en Biomedicina (FIBMED): lead
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Puerta de Hierro University Hospital: collaborator

Study Sites (3)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Angel Arenal, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control and treatment arms. Control group refers to pulmonary vein isolation ablation. Treatment group refers to pulmonary vein isolation plus radial ablation of rotational activity sites.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 10, 2020
• Study Start: March 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)