Radial Ablation for the Control of Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— ARTIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662489
• Other study ID #: ARTIST
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Fundacion para la Innovacion en Biomedicina (FIBMED)
• Contact: Angel Arenal, MD, PhD
• Phone: 0034915868290
• Email: arenal[@]secardiologia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein electrical isolation
Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy
• Radial ablation
Electrical isolation of the pulmonary veins from the left atrium plus radial ablation of rotational activity sites with radiofrequency ablation.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Fundacion para la Innovacion en Biomedicina (FIBMED)	Hospital General Universitario Gregorio Marañon, Hospital Universitario 12 de Octubre, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	2 years
Secondary	Total and cardiac mortality	Total and cardiac mortality; Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.	2 years
Secondary	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.	1 year