Evaluating high power short duration RF for atrial fibrillation ablation
Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)
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 type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Clinica Mediterranea Academic / other |
| Locations | 9 sites (Paris and 8 other locations) |
| Trial ID | NCT05777551 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with paroxysmal or persistent atrial fibrillation who are on active oral anticoagulation.
Not a fit: Patients who have previously undergone ablation for atrial fibrillation or have significant heart failure may not benefit from this study.
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 performed: While this approach is being evaluated in this study, similar techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
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 this trial is running
Paris and 8 other locations
- 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)
- 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
- Study coordinator: Giuseppe Stabile, MD
- Email: gmrstabile@tin.it
- Phone: +393488960534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.