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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185412 on ClinicalTrials.gov