RecruitingNCT05777551

AF Ablation With High Power Short Duration RF

Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)

Sponsor

Clinica Mediterranea

Enrollment

850 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Catheter Ablation

Summary

This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF). Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters). Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD. At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining a newer way to treat atrial fibrillation (an irregular heartbeat) using a heart ablation procedure. The technique uses high-powered, short-duration radiofrequency energy to disrupt the faulty electrical signals causing the irregular rhythm. Researchers want to see if this approach is effective and safe. **You may be eligible if:** - You have been diagnosed with paroxysmal (comes and goes) or persistent atrial fibrillation - You are currently taking blood thinners (oral anticoagulants) - You are willing to sign an informed consent form **You may NOT be eligible if:** - You have previously had an ablation procedure for atrial fibrillation - Your heart's pumping function is significantly reduced (ejection fraction below 35%) - You are pregnant or may be pregnant - You have a reason to avoid X-ray exposure - You have a congenital heart condition or have had heart surgery within the last month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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