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NOT YET RECRUITING
NCT07815171
NA

Lattice vs Pentaspline Comparative Evaluation in Persistent AF

Sponsor: Mitera Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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