Multitarget pulse-field ablation guided by heart and body-surface mapping for long-standing atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm prospective pilot testing a multitarget pulsed field ablation (PFA) strategy guided by endocardial intracavitary electrograms and noninvasive body-surface driver mapping (ECGi). The approach aims to identify and ablate extra-pulmonary vein AF drivers and rotors to reproduce the multilevel substrate modification of a Cox‑Maze IV while using the tissue-selective, non-thermal properties of PFA to reduce collateral injury. Eligible patients are adults with symptomatic long‑standing persistent AF and either heart failure or a high comorbidity burden who have failed or cannot take antiarrhythmic drugs. Outcomes will focus on procedural safety, feasibility, and arrhythmia recurrence after the combined mapping-guided multitarget ablation.

Why it matters

Who can join: the full rules

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%.

Where it's running

• Hospital General Universitario Gregorio Marañon
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Angel Arenal, MD, PhD — Hospital General Universitario Gregorio Marañon
• Study coordinator: Angel Arenal, MD, PhD
• Email: arenal@secardiologia.es
• Phone: 0034915868290

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.