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Lattice vs Pentaspline Comparative Evaluation in Persistent AF
Sponsor: Mitera Hospital
Summary
LANCE-AF is a prospective, multicenter, multinational, randomized, non-inferiority trial comparing two pulsed-field ablation catheter technologies-the Sphere-9 lattice-tip catheter and the FARAPULSE pentaspline catheter-in patients with symptomatic persistent atrial fibrillation. In both treatment groups, atrial fibrillation ablation will be restricted to pulmonary vein isolation. Empirical left atrial substrate modification will not be permitted. An insertable cardiac rhythm monitor will be implanted during the index procedure to provide continuous rhythm monitoring for 12 months. The primary objective is to determine whether ablation using the Sphere-9 catheter is non-inferior to ablation using the FARAPULSE catheter with respect to acute pulmonary vein isolation and freedom from treatment failure through 12 months. Secondary objectives include comparisons of procedural safety, postablation atrial arrhythmia burden, longest atrial arrhythmia episode, quality of life, and procedural efficiency.
Official title: Lattice-tip Versus Pentaspline Catheter for Pulsed-Field Ablation of Persistent Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2027-03
Completion Date
2030-03
Last Updated
2026-09-15
Healthy Volunteers
No
Conditions
Interventions
Pulmonary vein isolation
The use of general anesthesia is mandatory for all study procedures. All patients presenting in a non-sinus rhythm will be cardioverted to sinus rhythm. Pulmonary vein isolation constitutes the sole permitted ablation lesion set for atrial fibrillation; empirical left atrial substrate modification is not allowed. Cavotricuspid isthmus ablation will be the only non-pulmonary vein isolation ablation permitted and must be strictly confined to patients with documented typical atrial flutter.
Locations (10)
Institut de Cardiologie, Hôpital Universitaire Pitié-Salpêtriere, AP-HP, Sorbonne Université
Paris, France
Department of Cardiology, Jean Monnet University
Saint-Etienne, France
1st Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion Hospital
Athens, Greece
7th Cardiology Department, Hygeia Hospital
Athens, Greece
8th Cardiology Department, Hygeia Hospital
Athens, Greece
Heart Rhythm Center, IASO Hospital
Athens, Greece
Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medical Center
Rotterdam, Netherlands
Cardiology Department, 12th of October University Hospital
Madrid, Spain
Servicio de Cardiología, Hospital Universitari, Politecnic La Fe, Valencia, Spain
Valencia, Spain
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern
Bern, Switzerland