Multitarget pulse-field ablation guided by heart and body-surface mapping for long-standing atrial fibrillation
Multitarget Pulse Field Ablation Guided by Endocardial and Non-invasive Atrial Driver Mapping (PFA+ADM) Pilot Study. Development of an Ablation Strategy to Improve the Efficacy of Long Standing Atrial Fibrillation Ablation in Patients With High Comorbidity Burden or Heart Failure
This pilot test tries a new catheter pulsed-field ablation guided by internal and noninvasive electrical mapping to treat people with long-standing persistent atrial fibrillation who have heart failure or many other health problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundacion para la Innovacion en Biomedicina (FIBMED) Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07118488 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 with symptomatic long‑standing persistent AF who have failed or cannot tolerate antiarrhythmic drugs and have heart failure (NYHA II–III or LVEF ≤50%) or a high comorbidity burden (e.g., CHA2DS2‑VASc ≥4) and can consent to the protocol.
Not a fit: Patients unlikely to benefit include those with very large left atria (>5.5 cm), prior left atrial ablation or surgery, pulmonary vein stents/stenosis, pre-existing diaphragmatic paralysis, significant valve prostheses or disease, recent cardiac surgery/intervention, or unstable NYHA class IV heart failure.
Why it matters
Potential benefit: If successful, the approach could lower AF recurrence and improve symptoms in a difficult-to-treat group while reducing collateral damage compared with some thermal ablation methods.
How similar studies have performed: Pulsed field ablation has shown promising safety and PV isolation results and surgical Cox‑Maze procedures are effective for durable rhythm control, but combining PFA with noninvasive driver mapping to target extra‑PV drivers is a novel strategy with limited direct evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid, Madrid
- Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Angel Arenal, MD, PhD — Hospital General Universitario Gregorio Marañón
- Study coordinator: Angel Arenal, MD, PhD
- Email: arenal@secardiologia.es
- Phone: 0034915868290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.