Clinical trial Recruiting at 7 sites Observational Ages 18 to 80

Evaluating high power short duration RF for atrial fibrillation ablation

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

Run by Clinica Mediterranea · NCT05777551 · Data updated 2026-11-12

This study is testing a new way to use radiofrequency energy for heart ablation to see if it helps people with atrial fibrillation feel better and stay healthy over the next year.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment850 (estimated)
SponsorClinica Mediterranea
Academic / other
Locations9 sites (Paris and 8 other locations)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedMarch 5, 2024
Trial IDNCT05777551 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with paroxysmal or persistent atrial fibrillation who are on active oral anticoagulation.

Probably not a fit

Patients who have previously undergone ablation for atrial fibrillation or have significant heart failure may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and efficacy of pulmonary vein isolation using high power short duration radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation. Participants will undergo catheter ablation with commercially approved devices and will be followed for 12 months to monitor the recurrence of atrial fibrillation and identify predictors of outcomes. The study plans to enroll at least 850 patients to ensure adequate statistical power for analyzing the primary endpoint, which focuses on the relationship between clinical characteristics and the effectiveness of the procedure.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes and reduced recurrence rates for patients with atrial fibrillation.

How similar studies have gone: While this approach is being evaluated in this study, similar techniques have shown promise in other studies, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

  • Centre Cardiologique Du Nord
    Paris, France
    Recruiting
  • Clinica Montevergine
    Mercogliano, Av, Italy
    Recruiting
  • Maria cecilia Hospital
    Cotignola, Ra, Italy
    Recruiting
  • Ospedale di Conegliano
    Conegliano, Tv, Italy
    Recruiting
  • Università Politecnica delle Marche
    Ancona, Italy
    Recruiting
  • Ospedale Civile di Asti
    Asti, Italy
    Recruiting
Show 3 more locations
  • Clinica Mediterranea
    Naples, Italy
    Recruiting
  • Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.
    Torino, Italy
    Not yet recruiting
  • Royal Papworth Hospital
    Cambridge, United Kingdom
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.