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Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation

NCT06085014 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-10-16

No results posted yet for this study

Summary

From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.

Conditions

  • Atrial Fibrillation Paroxysmal

Interventions

OTHER

Standard of care

All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed

OTHER

Data collection

There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Ospedali Riuniti

    collaborator OTHER

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Stefania Riva, MD · IRCCS Centro Cardiologico Monzino

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Italy

Study Locations

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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 NCT06085014 on ClinicalTrials.gov