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Persistent Atrial FibrillationARTISTNCT04662489

Radial Ablation for the Control of Persistent Atrial Fibrillation

A study testing Pulmonary vein electrical isolation and Radial ablation in people with Persistent Atrial Fibrillation, run by Fundacion para la Innovacion en Biomedicina (FIBMED) at 3 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
Pulmonary vein electrical isolation and Radial ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
3 sitesSpain
Study dates
1 Mar 2022to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participation in another study so as not to interfere with the results.
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  • Previous atrioventricular block.
  • Pericardial effusion.
  • Pregnancy or childbearing age without contraceptive treatment.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28009

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Pulmonary vein electrical isolation, Radial ablation
Keywords
Atrial fibrillation, Catheter ablation, Radial ablation, Rotors
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary vein electrical isolationProcedure or surgery

    Also called Pulmonary veins ablation

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

  • Radial ablationProcedure or surgery

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

Study groups in NCT04662489
Study groupRoleWhat they receive
Control arm. Pulmonary vein isolationActive comparatorPulmonary vein isolation with ablation.
Receives: Procedure: Pulmonary vein electrical isolation
Treatment arm. Radial ablationExperimentalPulmonary vein isolation plus radial ablation of rotational activity sites.
Receives: Procedure: Radial ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (10)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. Accute procedural success rate

    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.

    Measured: 2 years

  4. Occurrence of hospitalization for cardiovascular cause

    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.

    Measured: 1 year

  5. Cerebrovascular accident unforeseen hospitalization

    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.

    Measured: 1 year

  6. Heart failure unforeseen hospitalization

    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.

    Measured: 1 year

  7. Functional class worsening unforeseen hospitalization

    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.

    Measured: 1 year

  8. Final functional class at the end of the study

    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.

    Measured: 2 years

  9. Total and cardiac mortality

    Total and cardiac mortality

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

    Measured: 2 years

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

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start1 Mar 2022
  3. Primary completionJan 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662489
Sponsor's protocol ID
ARTIST
Acronym
ARTIST
Status last verified
Mar 2025
First submitted
24 Nov 2020
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary vein electrical isolation and Radial ablation in people with Persistent Atrial Fibrillation, run by Fundacion para la Innovacion en Biomedicina (FIBMED) at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation burden (1 year) (time frame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04662489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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