Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry.
Giuseppe Stabile, Antoine Lepillier, Ermenegildo De Ruvo...
https://pubmed.ncbi.nlm.nih.gov/32369225Actively Recruiting
Led by Clinica Mediterranea · Updated on 2024-03-05
850
Participants Needed
9
Research Sites
52 weeks
Total Duration
Researchers are evaluating the safety and effectiveness of pulmonary vein isolation (PVI) using high power short duration (HPSD) radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation (AF). This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedure's overall safety and efficacy.
CONDITIONS
AF Ablation With High Power Short Duration RF
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo atrial fibrillation ablation using a high power short duration radiofrequency catheter with sedation or anesthesia as preferred by the center.
1 procedure visit (in-person)
Duration - 1 day
Participants receive a post-procedural ECG and optional echocardiogram to check for acute complications after ablation.
1 visit (in-person) immediately after procedure
Duration - Up to 12 months
Participants attend scheduled follow-up assessments including history, physical exam, ECG, and 24-hour Holter monitoring to check for arrhythmia recurrence.
Visits at 3 months and additional detailed follow-up at 6 to 12 months
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
G
Giuseppe Stabile, MD
T
Teresa Strisciuglio, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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