Radial Ablation for the Control of Persistent Atrial Fibrillation (ARTIST)

March 10, 2025 updated by: Fundacion para la Innovacion en Biomedicina (FIBMED)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control arm. Pulmonary vein isolation
Pulmonary vein isolation with ablation.
Procedure: Pulmonary vein electrical isolation
Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy
Other Names:
  • Pulmonary veins ablation
Experimental: Treatment arm. Radial ablation
Pulmonary vein isolation plus radial ablation of rotational activity sites.
Procedure: Radial ablation
Electrical isolation of the pulmonary veins from the left atrium plus radial ablation of rotational activity sites with radiofrequency ablation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
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.
Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
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.
Patients will be followed up during one year, regardless of reaching or not the primary endpoint.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
2 years
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.
2 years
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion para la Innovacion en Biomedicina (FIBMED)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Universitario Gregorio Marañon
Hospital Universitario 12 de Octubre
Puerta de Hierro University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angel Arenal, MD, PhD, Hospital General Universitario Gregorio Marañon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARTIST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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