Clinical trial NCT04662489: Radial Ablation for the Control of Persistent Atrial Fibrillation
Official title: Radial Ablation for the Control of Persistent Atrial Fibrillation (Ablación Radial Para conTrol de la fibrilación Auricular persISTtente)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Catheter ablation
Radial ablation
Rotors
Lead sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED)
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario 12 de Octubre
name: Puerta de Hierro University Hospital
First posted: 2020-12-10
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Atrial fibrillation burden (1 year)
timeFrame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
measure: Atrial flutter burden (1 year)
timeFrame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
measure: Atrial tachycardia burden (1 year)
timeFrame: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Secondary outcomes:
measure: Occurrence of severe complication of the ablation procedure
timeFrame: 2 years
measure: Overall clinical procedure, radiofrequency and fluoroscopy durations
timeFrame: 2 years
measure: Accute procedural success rate
timeFrame: 2 years
measure: Occurrence of hospitalization for cardiovascular cause
timeFrame: 1 year
measure: Cerebrovascular accident unforeseen hospitalization
timeFrame: 1 year
measure: Heart failure unforeseen hospitalization
timeFrame: 1 year
measure: Functional class worsening unforeseen hospitalization
timeFrame: 1 year
measure: Final functional class at the end of the study
timeFrame: 2 years
measure: Total and cardiac mortality
timeFrame: 2 years
measure: Quality of life measured with the The Short Form (36) Health Survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Angel Arenal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: