Pulmonary vein electrical isolation
ProcedureElectrical isolation of the pulmonary veins from the left atrium with cryoablation therapy
Other names: Pulmonary veins ablation
NCT Number: NCT04662489
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.
This study is active but is not currently recruiting participants.
18 year–75 year
All sexes
Interventional
Not applicable
Hospital General Universitario Gregorio Marañon, Madrid, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy
Other names: Pulmonary veins ablation
Electrical isolation of the pulmonary veins from the left atrium plus radial ablation of rotational activity sites with radiofrequency ablation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 2 years
Total and cardiac mortality
Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
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.
Fundacion para la Innovacion en Biomedicina (FIBMED)
Other
Radial Ablation for the Control of Persistent Atrial Fibrillation (Ablación Radial Para conTrol de la fibrilación Auricular persISTtente)
Acronym: ARTIST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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