Actively Recruiting
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
Led by Fundacion para la Innovacion en Biomedicina (FIBMED) · Updated on 2025-08-12
50
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Ability and willingness to follow the study protocol and provide informed consent
- Symptomatic long-standing atrial fibrillation for at least one month documented by ECG or device recordings
- History of failure, intolerance, or refusal of antiarrhythmic drug therapy
- New York Heart Association functional class II or III, or left ventricular dysfunction with ejection fraction 50% or less, or a CHA2DS2-VASc score of 4 or more
- For patients with left ventricular dysfunction, optimal medical treatment for heart failure for at least three months
You will not qualify if you...
- Left atrial diameter greater than 5.5 cm
- Previous left atrial ablation or surgery
- No anticoagulation therapy for 3 weeks before the procedure
- Presence of 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 or New York Heart Association class IV heart failure
- Pulmonary hypertension or rheumatic heart disease
- Blood clotting disorders or contraindications to chronic anticoagulation
- Active infection or hypertrophic cardiomyopathy
- Reversible causes of atrial fibrillation such as hyperthyroidism or sleep apnea
- Stroke or transient ischemic attack in the past 6 months
- History of thromboembolic events or 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 or provide consent
- Left ventricular ejection fraction 25% or less
- New York Heart Association class IV heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28009
Actively Recruiting
Research Team
A
Angel Arenal, MD, PhD
CONTACT
G
Gonzalo Ricardo Ríos-Muñoz, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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