NCT07118488Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Fundacion para la Innovacion en Biomedicina (FIBMED)
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07118488
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Aug 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrial ablation or surgery.
- Lack of anticoagulation therapy for 3 weeks prior to the procedure.
Other illness
- 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.
Lab values
- Left ventricular ejection fraction ≤ 25%.
Age
- Women of childbearing age
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.