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

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• Patients with paroxysmal/persistent AF who signed the informed consent

• Patients on active oral anticoagulation

Locations
Other Locations
France
Centre Cardiologique Du Nord
RECRUITING
Paris
Italy
Università Politecnica delle Marche
RECRUITING
Ancona
Ospedale Civile di Asti
RECRUITING
Asti
Ospedale di Conegliano
RECRUITING
Conegliano
Maria cecilia Hospital
RECRUITING
Cotignola
Clinica Montevergine
RECRUITING
Mercogliano
Clinica Mediterranea
RECRUITING
Napoli
Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.
NOT_YET_RECRUITING
Torino
United Kingdom
Royal Papworth Hospital
NOT_YET_RECRUITING
Cambridge
Contact Information
Primary
Giuseppe Stabile, MD
gmrstabile@tin.it
+393488960534
Backup
Teresa Strisciuglio, MD
teresa.strisciuglio@unina.it
+393293238130
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 850
Related Therapeutic Areas
Sponsors
Leads: Clinica Mediterranea

This content was sourced from clinicaltrials.gov