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RecruitingNot ApplicableNCT07118488

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

Sponsor

Fundacion para la Innovacion en Biomedicina (FIBMED)

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Persistent Atrial Fibrillation Longstanding

Summary

To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria23

  • 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%.

Interventions

PROCEDUREMultitarget PFA Ablation

* Informed consent gave by the patient. * Implantable loop recorder procedure * Clinical procedure starts * Electrophysiologycal study * Non-invasive map is obtained. * Electroanatomical map of both atria is generated. * Intracavitary electrogram (EGM) driver assessment * Pulmonary vein isolation * Extra pulmonary drivers ablation based on EGM findings (rotational and high frequency sites). * Non-invasive map is obtained to assess ablation impact on driver distribution. * Remap and extra pulmonary lesions are carried out until activity. At drivers sites disappears or decreases in at least 2 hertz or up to physician criteria. * Patient follow up

Locations(1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

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NCT07118488