Multitarget Pulse Field Ablation Guided by Endocardial and Non-invasive Atrial Driver Mapping (PF… (NCT07118488) | Clinical Trial Compass
RecruitingNot Applicable
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
Spain50 participantsStarted 2025-08
Plain-language summary
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Inab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Successful Pulmonary Vein Isolation and Freedom from Atrial Fibrillation or Reduction in Arrhythmia Burden
Timeframe: 1 year
2
Incidence of Procedure-Related Complications, Including Mortality, Pulmonary Vein Stenosis, Nerve Injury, Stroke, and Major Bleeding Events [Safety]
Timeframe: 6 months
Trial details
NCT IDNCT07118488
SponsorFundacion para la Innovacion en Biomedicina (FIBMED)