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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)
Atrial fibrillation burden (1 year) — 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.
Atrial flutter burden (1 year) — 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.
Atrial tachycardia burden (1 year) — 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.
Trial sites (3)
Facility
City
Region
Status
Hospital General Universitario Gregorio Marañon
Madrid
Madrid
Hospital Universitario 12 de Octubre
Madrid
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Madrid
More Fundacion para la Innovacion en Biomedicina (FIBMED) trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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