Testing a new catheter ablation method for long-lasting atrial fibrillation
Tests a multi-site pulse field ablation procedure in adults with long-standing atrial fibrillation.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07118488, who can take part
Where in Spain
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion para la Innovacion en Biomedicina (FIBMED)
- Trial code
- NCT07118488
- Record updated
- 12 August 2025
- Original description
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.Read full original descriptionShow less
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
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
Inclusion: 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: Previous left atrial ablation or surgery; Lack of anticoagulation therapy for 3 weeks prior to the procedure; 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; Active infection or hypertrophic cardiomyopathy; Stroke or TIA in the past 6 months; History of thromboembolic events or evidence of intracardiac thrombus; Allergy to adhesives; NYHA Class IV heart failure; Left ventricular ejection fraction ≤ 25%; Women of childbearing age; Left atrial diameter >5.5 cm; Pulmonary vein stents or stenosis; Pre-existing diaphragmatic paralysis; Contraindications to chronic anticoagulation; Reversible causes of AF, such as hyperthyroidism or sleep apnea; Life expectancy less than 12 months; Participation in another clinical trial; Inability to comply with study procedures; Inability to provide personal consent.