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

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

Inclusion Criteria2

  • Patients with paroxysmal/persistent AF who signed the informed consent
  • Patients on active oral anticoagulation

Exclusion Criteria5

  • Previous ablation for AF
  • Patients with LVEF\<35%
  • Women potentially pregnant
  • Contraindications to X-ray exposure
  • Congenital heart disease or cardiac surgery within 1 month

Locations(9)

Centre Cardiologique Du Nord

Paris, France

Clinica Montevergine

Mercogliano, AV, Italy

Maria cecilia Hospital

Cotignola, RA, Italy

Ospedale di Conegliano

Conegliano, TV, Italy

Università Politecnica delle Marche

Ancona, Italy

Ospedale Civile di Asti

Asti, Italy

Clinica Mediterranea

Napoli, Italy

Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.

Torino, Italy

Royal Papworth Hospital

Cambridge, United Kingdom

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NCT05777551


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