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

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation Longstanding

In brief

To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.

Key facts

Study ID

NCT07118488

Run by

Fundacion para la Innovacion en Biomedicina (FIBMED)

People needed

50

Starts

2025-08-01

Expected to finish

2027-07-01

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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