NCT07815171Not yet recruiting
Lattice vs Pentaspline Comparative Evaluation in Persistent AF
Lattice-tip Versus Pentaspline Catheter for Pulsed-Field Ablation of Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- Mar 2027
- Primary completion date
- Mar 2030
- Lead sponsor
- Mitera Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07815171
What you commit to
- Study type: Interventional
- Planned participants: 250
- From Mar 2027 to the primary completion date, Mar 2030
- 10 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous catheter or surgical ablation, except right-sided atrial ablation for supraventricular tachycardia or cavotricuspid isthmus ablation for atrial flutter
- Prior pulmonary vein intervention, pulmonary vein stenting, or known severe pulmonary vein stenosis
- Presence of an interatrial baffle, ASD/PFO closure device, or surgical patch that, in the investigator's judgment, precludes safe transseptal access Cardiovascular exclusions
- Inability, unwillingness, or anatomical contraindication (e.g., implant-site skin or soft-tissue pathology, prior radiation, or chest-wall deformity) to undergo ILR implantation
Other illness
- New York Heart Association (NYHA) functional class III or IV
- Recent acute coronary syndrome, coronary revascularization, cardiac surgery, stroke, or transient ischemic attack within the preceding 90 days
- Severe valvular heart disease or prosthetic heart valve/annuloplasty ring
- History of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF).
- Atrial fibrillation secondary to reversible non-cardiac causes. Other exclusions
- Presence of an insertable cardiac device (pacemaker, ICD, CRT, or pre-existing non-study ILR)
Lab values
- Severe renal impairment: eGFR\<30 mL/min/1.73 m2 or current/prior renal replacement therapy
Other
- Anatomical and procedural exclusions
- Severe left atrial enlargement: left atrial anteroposterior diameter ≥55 mm or LAVI \>50 mL/m2
- Left atrial or left atrial appendage (LA/LAA) thrombus
- Contraindication or intolerance to therapeutic systemic anticoagulation
- Documented baseline hemi-diaphragmatic paresis or paralysis
- Pregnancy or planned pregnancy during the 12-month trial window
- Inability or unwillingness to provide informed consent or complete 12 months of trial follow-up
Who the study is looking for
- Age ≥ 18 years
- Symptomatic AF (EHRA symptom class ≥ II)
- Documented persistent AF (continuous AF for \> 7 days and \< 365 days), confirmed within 180 days of enrollment by either a 24-hour Holter recording showing continuous AF, or two ECGs from any regulatory-cleared rhythm monitoring device, taken at least 7 days apart, showing continuous AF
- Patients considered eligible for catheter ablation (either refractory/intolerant to ≥1 Class I/III AAD or presenting for first-line ablation per clinical discretion)
- Willing and capable of undergoing insertable loop recorder (ILR) implantation at the index procedure and maintaining the conditions required for automatic remote transmission throughout the 12-month study period
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, Inselspital, Bern University Hospital, University of Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Cardiology Department, 12th of October University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Servicio de Cardiología, Hospital Universitari, Politecnic La Fe, Valencia, Spain Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Institut de Cardiologie, Hôpital Universitaire Pitié-Salpêtriere, AP-HP, Sorbonne Université Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Department of Cardiology, Jean Monnet University Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| 8th Cardiology Department, Hygeia Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| 1st Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| 7th Cardiology Department, Hygeia Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Heart Rhythm Center, IASO Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.