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

NCT07118488 | Recruiting

• 1 other identifier: PFA+ADM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Persistent Atrial Fibrillation Longstanding

Keywords

Atrial fibrillation; PFA; Rotors; Atrial entanglement; Catheter ablation; ECGi

Outcome Measures

Primary Outcomes (2)

• Incidence of Successful Pulmonary Vein Isolation and Freedom from Atrial Fibrillation or Reduction in Arrhythmia Burden

  Success is defined as complete isolation of all pulmonary veins and either absence of atrial fibrillation recurrence or a significant reduction in arrhythmia burden over a 1-year follow-up period.

  1 year

• Incidence of Procedure-Related Complications, Including Mortality, Pulmonary Vein Stenosis, Nerve Injury, Stroke, and Major Bleeding Events [Safety]

  The safety endpoint is defined as maintaining a complication rate of ≤5%, assessed by monitoring for acute and long-term complications such as mortality, pulmonary vein stenosis, nerve injury, stroke, bleeding, and other serious adverse events occurring within 30 days to 6 months post-procedure.

  6 months

Secondary Outcomes (14)

• Percentage of patients in Per AF at the end of follow-up

  1 year

• Time to the first episode of atrial arrhythmia of more than 30 seconds

  1 year

• Percentage of patients with AF/AT recurrence

  1 year

• Percentage of patients with <50% of AF/AT burden

  1 year

• Left ventricular end-systolic volume at the end of follow-up

  1 year

Study Arms (1)

Single Arm - Multitarget PFA Ablation

EXPERIMENTAL

Pulmonary vein isolation plus extra pulmonary drivers ablation based on EGM findings (rotational and high frequency sites)

Procedure: Multitarget PFA Ablation

Interventions

Multitarget PFA Ablation PROCEDURE

* 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

Single Arm - Multitarget PFA Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Innovacion en Biomedicina (FIBMED): lead

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28009, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angel Arenal, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Arenal, MD, PhD

CONTACT

0034915868290; arenal@secardiologia.es

Gonzalo Ricardo Ríos-Muñoz, MSc, PhD

CONTACT

grios@ing.uc3m.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)