Spanish Registry of Redo Procedures Following Pulmonary Vein Ablation by Pulsed Field Ablation Technology: RESET-PFA
NCT07185412 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1100
Last updated 2025-09-22
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 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.
Conditions
- Cardiac Arrhythmia
- Atrial Fibrillation
- Pulsed Field Ablation
Interventions
- DEVICE
-
Pulsed Field ablation: Ablation to treat atrial fibrillation
Pulsed Field Ablation
Sponsors & Collaborators
-
Instituto de Investigación Sanitaria Aragón
lead OTHER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
Countries
- Spain
Study Locations
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