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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-08-12
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
Interventions
- PROCEDURE
-
Multitarget 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
Sponsors & Collaborators
-
Fundacion para la Innovacion en Biomedicina (FIBMED)
lead OTHER
Principal Investigators
-
Angel Arenal, MD, PhD · Hospital General Universitario Gregorio Marañón
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-31
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- Spain
Study Locations
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