Spanish Registry of Redo Procedures Following Pulmonary Vein Ablation by Pulsed Field Ablation Technology: RESET-PFA
Key facts
- Where
- Zaragoza, SpainSee the site
Where in Spain
- Unidad de Arritmias. Departamento de Cardiología. Hospital Universitario Lozano Blesa.Zaragoza, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Investigación Sanitaria Aragón
- Trial code
- NCT07185412
- Record updated
- 22 September 2025
- Original description
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 consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kinds of atrial arrhythmias and of all Adverse Events in the study population will be collected.Read full original descriptionShow less
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 consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kinds of atrial arrhythmias and of all Adverse Events in the study population will be collected.
The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 10 clinical and procedural parameters predicting a repeat ablation procedure after the blanking period in patients that had undergone an AF ablation with pulsed field ablation through a standard of care pathway.
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.