NCT05777551 AF Ablation With High Power Short Duration RF
| NCT ID | NCT05777551 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinica Mediterranea |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 850 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 850 participants in total. It began in 2023-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05777551 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05777551 currently recruiting?
Yes, NCT05777551 is actively recruiting participants. Contact the research team at gmrstabile@tin.it for enrollment information.
Where is the NCT05777551 trial being conducted?
This trial is being conducted at Paris, France, Mercogliano, Italy, Cotignola, Italy, Conegliano, Italy and 5 additional locations.
Who is sponsoring the NCT05777551 clinical trial?
NCT05777551 is sponsored by Clinica Mediterranea. The trial plans to enroll 850 participants.
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