Actively Recruiting
AF Ablation With High Power Short Duration RF
Led by Clinica Mediterranea · Updated on 2024-03-05
850
Participants Needed
9
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AF Ablation With High Power Short Duration RF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with paroxysmal or persistent atrial fibrillation who have signed informed consent
- Patients currently using oral anticoagulation medication
You will not qualify if you...
- Previous ablation treatment for atrial fibrillation
- Left ventricular ejection fraction less than 35%
- Women who may be pregnant
- Contraindications to X-ray exposure
- History of congenital heart disease or cardiac surgery within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Centre Cardiologique Du Nord
Paris, France
Actively Recruiting
2
Clinica Montevergine
Mercogliano, AV, Italy
Actively Recruiting
3
Maria cecilia Hospital
Cotignola, RA, Italy
Actively Recruiting
4
Ospedale di Conegliano
Conegliano, TV, Italy
Actively Recruiting
5
Università Politecnica delle Marche
Ancona, Italy
Actively Recruiting
6
Ospedale Civile di Asti
Asti, Italy
Actively Recruiting
7
Clinica Mediterranea
Naples, Italy, 80100
Actively Recruiting
8
Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.
Torino, Italy
Not Yet Recruiting
9
Royal Papworth Hospital
Cambridge, United Kingdom
Not Yet Recruiting
Research Team
G
Giuseppe Stabile, MD
CONTACT
T
Teresa Strisciuglio, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here