Tests a high-power short-burst heart ablation for irregular heartbeat
Follows adults with atrial fibrillation treated with high-power short-duration catheter ablation.
Plain-language title generated from the registry record
Registry title: AF Ablation With High Power Short Duration RF
Key facts
- Where
- Ancona, Asti, Conegliano, Cotignola, Mercogliano, Naples, and Torino, ItalySee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05777551, who can take part
Where in Italy
- Universita Politecnica Delle MarcheAncona, ItalyTaking people
- Ospedale Civile di AstiAsti, ItalyTaking people
- Ospedale di ConeglianoConegliano, ItalyTaking people
- Maria Cecilia HospitalCotignola, ItalyTaking people
- Clinica MontevergineMercogliano, ItalyTaking people
- Clinica MediterraneaNaples, ItalyTaking people
- Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.Torino, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinica Mediterranea
- Trial code
- NCT05777551
- Record updated
- 5 March 2024
- Original description
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).Read full original descriptionShow less
Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)
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.
Inclusion: Patients with paroxysmal/persistent AF who signed the informed consent; Patients on active oral anticoagulation.
Exclusion: Previous ablation for AF; Congenital heart disease or cardiac surgery within 1 month; Patients with LVEF<35%; Women potentially pregnant; Contraindications to X-ray exposure.