Lattice vs Pentaspline Comparative Evaluation in Persistent AF

NCT07815171 | Not Yet Recruiting DMC

• 1 other identifier: 230826v12
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 10

Brief 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.

Conditions

Persistent Atrial Fibrillation

Keywords

atrial fibrillation; persistent atrial fibrillation; catheter ablation; pulsed field ablation; insertable loop recorder

Outcome Measures

Primary Outcomes (1)

• Number of participants with acute ablation success and freedom from treatment failure.

  The primary endpoint will be the number of participants with acute ablation success (achievement of pulmonary vein isolation, confirmed by entrance block in all treated veins) and freedom from treatment failure through 12 months. Treatment failure is defined as the first occurrence of any of the following, assessed from the end of the 2-month blanking period onward, except for amiodarone use, which is assessed from the time of the index ablation: 1. Atrial fibrillation/atrial flutter/atrial tachycardia recurrence lasting ≥ 6 minutes, as documented by the implantable loop recorder 2. Cardioversion (electrical or pharmacological) for atrial fibrillation/atrial flutter/atrial tachycardia 3. Repeat ablation for atrial fibrillation/atrial flutter/atrial tachycardia 4. Use of a Class I or Class III antiarrhythmic drug after the blanking period, or any amiodarone use at any time after the index ablation, including during the blanking period

  From the index procedure to the end of the follow-up at 12 months.

Secondary Outcomes (14)

• Number of participants with device- and procedure-related complications

  From the index procedure up to 30 days post intervention.

• Percentage of monitored time spent in atrial fibrillation/atrial flutter/atrial tachycardia

  From the end of the 2-month blanking period through 12 months after ablation.

• Number of participants with an atrial fibrillation/atrial flutter/atrial tachycardia burden below 0.1%

  From the end of the 2-month blanking period through 12 months after ablation.

• Duration of the longest postablation atrial fibrillation/atrial flutter/atrial tachycardia episode

  From the end of the 2-month blanking period until the earliest rhythm-altering intervention or 12 months after ablation.

• Change from baseline in the EQ-5D-5L utility index at 12 months

  Baseline and 12 months after ablation.

Study Arms (2)

Sphere-9

OTHER

In the Sphere-9 arm, only pulsed field applications will be used for point-by-point antral pulmonary vein isolation. Deployment of linear lesions along the right and left pulmonary vein carinas is strongly recommended in the absence of a common ostium, ensuring balanced anatomical lesion sets equivalent to the intrinsic carinal coverage achieved with the pentaspline catheter during superior and inferior vein deployments. To aim for contiguous lesions, an inter-lesion distance of 5 mm should be argeted and tissue contact should be confirmed using impedence measures and real time monitoring of the temperature rise in the appropriate graph. In patients with documented typical atrial flutter, cavotricuspid isthmus ablation will be performed with the Sphere-9 catheter using radiofrequency energy only.

Procedure: Pulmonary vein isolation

Farapulse

OTHER

In the Farapulse arm, procedural guidance with three-dimensional electroanatomical mapping using OPAL HDx system with the FARAVIEW module is mandatory. Pulmonary vein isolation will be performed with a minimum of 8 applications per pulmonary vein (4 "basket"-configuration and 4 "flower"-configuration applications). Additional applications may be delivered at operator discretion to achieve entrance block and will be systematically recorded. In patients with documented typical atrial flutter, operators may perform cavotricuspid isthmus ablation using either the pentaspline catheter with standard precautions, including prophylactic nitroglycerin per institutional protocol, or a standard commercially approved focal ablation catheter, at operator discretion. Use of the Sphere-9 catheter in the Farapulse arm is prohibited.

Procedure: Pulmonary vein isolation

Interventions

Pulmonary vein isolation PROCEDURE

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.

Farapulse; Sphere-9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous catheter or surgical ablation, except right-sided atrial ablation for supraventricular tachycardia or cavotricuspid isthmus ablation for atrial flutter
• Severe left atrial enlargement: left atrial anteroposterior diameter ≥55 mm or LAVI \>50 mL/m2
• Left atrial or left atrial appendage (LA/LAA) thrombus
• Prior pulmonary vein intervention, pulmonary vein stenting, or known severe pulmonary vein stenosis
• 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).
• Presence of an insertable cardiac device (pacemaker, ICD, CRT, or pre-existing non-study ILR)
• Contraindication or intolerance to therapeutic systemic anticoagulation
• Documented baseline hemi-diaphragmatic paresis or paralysis
• Inability, unwillingness, or anatomical contraindication (e.g., implant-site skin or soft-tissue pathology, prior radiation, or chest-wall deformity) to undergo ILR implantation
• Severe renal impairment: eGFR\<30 mL/min/1.73 m2 or current/prior renal replacement therapy
• 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

Sponsors & Collaborators

• Mitera Hospital: lead

Study Sites (10)

Institut de Cardiologie, Hôpital Universitaire Pitié-Salpêtriere, AP-HP, Sorbonne Université

Paris, France

Location

Department of Cardiology, Jean Monnet University

Saint-Etienne, France

Location

1st Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion Hospital

Athens, Greece

Location

7th Cardiology Department, Hygeia Hospital

Athens, Greece

Location

8th Cardiology Department, Hygeia Hospital

Athens, Greece

Location

Heart Rhythm Center, IASO Hospital

Athens, Greece

Location

Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medical Center

Rotterdam, Netherlands

Location

Cardiology Department, 12th of October University Hospital

Madrid, Spain

Location

Servicio de Cardiología, Hospital Universitari, Politecnic La Fe, Valencia, Spain

Valencia, Spain

Location

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stylianos Tzeis

  Cardiology Department, Mitera Hospital, Hygeia Group, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stylianos Tzeis, MD, PhD, FESC, FEHRA

CONTACT

+302106869777; steis@otenet.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology Department, Mitera Hospital, Hygeia Group, Athens, Greece

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

GR (4); NL (1); FR (2); ES (2); CH (1)