Status:
NOT_YET_RECRUITING
Spanish Registry of Redo Procedures Following Pulmonary Vein Ablation by Pulsed Field Ablation Technology: RESET-PFA
Lead Sponsor:
Instituto de Investigación Sanitaria Aragón
Conditions:
Cardiac Arrhythmia
Atrial Fibrillation
Eligibility:
All Genders
Brief Summary
RESET-PFA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of cons...
Detailed Description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in clinical practice in the Western world, significantly impacting patient morbidity and mortality. Catheter ablation, specific...
Eligibility Criteria
Inclusion
- Patients with an indication to a pulsed-field ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU or per physician discretion
- Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center or such consent will be provided by a legal representative, if required by local law or regulation.
Exclusion
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
- Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
- Life expectancy ≤ 12 months per physician judgment.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT07185412
Start Date
October 1 2025
End Date
December 31 2030
Last Update
September 22 2025
Active Locations (1)
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1
Unidad de Arritmias. Departamento de Cardiología. Hospital Universitario Lozano Blesa.
Zaragoza, Zaragoza, Spain, 50009