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 · NCT07118488 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED)
View the official record on ClinicalTrials.gov →Interventions studied
Multitarget PFA Ablation
What this trial is about
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- Hospital General Universitario Gregorio Marañon - Madrid, Madrid, Spain
- Hospital General Universitario Gregorio Marañon - Madrid, Madrid, Spain