💬In plain words
What the trial is, and whether it could suit you
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age between 18 and 80.
* Ability and willingness to follow the study protocol, including informed consent.
* Symptomatic long-standing AF for at least one month, documented by ECG or dual-chamber device recordings.
* History of failure, intolerance, or refusal of antiarrhythmic drug therapy.
* New York Heart Association (NYHA) functional class II or III, or left ventricular dysfunction (LVEF ≤ 50%) or a CHA2DS2-VASc score of 4 or more.
* Optimal medical treatment for heart failure for at least three months for patients with left ventricular dysfunction.
Exclusion Criteria:
* Left atrial diameter \>5.5 cm.
* Previous left atrial ablation or surgery.
* Lack of anticoagulation therapy for 3 weeks prior to the procedure.
* Pulmonary vein stents or stenosis.
* Pre-existing diaphragmatic paralysis.
* Cardiac valve prosthesis or significant valve disease.
* Recent cardiac surgery or interventions within the past 3 months.
* Unstable angina, NYHA Class IV heart failure.
* Pulmonary hypertension or rheumatic heart disease.
* Blood clotting disorders.
* Contraindications to chronic anticoagulation.
* Active infection or hypertrophic cardiomyopathy.
* Reversible causes of AF, such as hyperthyroidism or sleep apnea.
* Stroke or TIA in the past 6 months.
* History of thromboembolic events or evidence of intracardiac thrombus.
* Women of childbearing age
* Life expectancy less than 12 months.
* Participation in another clinical trial.
* Allergy to adhesives.
* Inability to comply with study procedures.
* Inability to provide personal consent.
* NYHA Class IV heart failure.
* Left ventricular ejection fraction ≤ 25%.
Hospital General Universitario Gregorio Marañon
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky