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 type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 850 (estimated) |
| Sponsor | Clinica Mediterranea Academic / other |
| Locations | 9 sites (Paris and 8 other locations) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | March 5, 2024 |
| Trial ID | NCT05777551 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
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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
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Personalized wide-area radiofrequency ablation plus pulmonary vein isolation versus pulsed-field pulmonary vein isolation for paroxysmal atrial fibrillation
This trial will test whether a patient-tailored radiofrequency ablation that targets extra atrial sources plus pulmonary vein isolation prevents recurrent atrial fibrillation better than pulsed-field pulmonary vein isolation in adults with paroxysmal AF.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities
This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.
-
Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation
This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.
-
Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II
This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.
-
4D intracardiac echocardiography to guide left atrial appendage occlusion procedures
A new 4D ICE catheter is being tested alongside standard imaging to see if it can safely guide left atrial appendage occlusion procedures for adults with atrial fibrillation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.