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OpenTrials
Active, Not Recruiting

NCT Number: NCT04662489

Radial Ablation for the Control of Persistent Atrial Fibrillation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario Gregorio Marañon, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary vein electrical isolation

Procedure

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

Other names: Pulmonary veins ablation

Radial ablation

Procedure

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

Primary outcomes

  1. Atrial fibrillation burden (1 year)

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

    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.

  2. Atrial flutter burden (1 year)

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

    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.

  3. Atrial tachycardia burden (1 year)

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

    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.

Secondary outcomes

  1. Occurrence of severe complication of the ablation procedure

    Time frame: 2 years

    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.

  2. Overall clinical procedure, radiofrequency and fluoroscopy durations

    Time frame: 2 years

    Total time registered during the clinical procedure.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  3. Accute procedural success rate

    Time frame: 2 years

    Accute procedural success as the percentage of episodes that revert to sinus flutter or sinus rhythm during the ablation procedure.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  4. Occurrence of hospitalization for cardiovascular cause

    Time frame: 1 year

    Unforeseen hospitalization for cardiovascular cause requiring overnight hospital stay during the 12 month follow-up.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  5. Cerebrovascular accident unforeseen hospitalization

    Time frame: 1 year

    Unforeseen hospitalization due to cerebrovascular accident (CVA) requiring overnight hospital stay during the 12 month follow-up.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  6. Heart failure unforeseen hospitalization

    Time frame: 1 year

    Unforeseen hospitalization due to new diagnosis for heart failure requiring overnight hospital stay during the 12 month follow-up.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  7. Functional class worsening unforeseen hospitalization

    Time frame: 1 year

    Unforeseen hospitalization due to functional class worsening due to heart failure requiring overnight hospital stay during the 12 month follow-up.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  8. Final functional class at the end of the study

    Time frame: 2 years

    Final functional class at the end of the study. New York Heart Association (NYHA) classification.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  9. Total and cardiac mortality

    Time frame: 2 years

    Total and cardiac mortality

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

  10. Quality of life measured with the The Short Form (36) Health Survey

    Time frame: 1 year

    Quality of life is measured with the The Short Form (36) Health Survey at pre-specified study follow-up visits (4, 8, 12 months).

    The short-form (36) health survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Sponsors and collaborators

Lead sponsor

Fundacion para la Innovacion en Biomedicina (FIBMED)

Other

Collaborators

  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario 12 de Octubre
  • Puerta de Hierro University Hospital

Registry information

Official study title

Radial Ablation for the Control of Persistent Atrial Fibrillation (Ablación Radial Para conTrol de la fibrilación Auricular persISTtente)

Acronym: ARTIST

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2020
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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