Lattice vs Pentaspline Comparative Evaluation in Persistent AF
ConditionPersistent Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMitera Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary vein isolation
Procedure/SurgeryThe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Sphere-9Other 1 intervention
Group B: FarapulseOther 1 intervention
Trial outcomes
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
Time frame
From the index procedure to the end of the follow-up at 12 months.Secondary outcomes
1
Number of participants with device- and procedure-related complications
Number of participants experiencing at least on of the following pre-specified acute and chronic device- and procedure-related adverse events, per the recent AFib-ARC recommendations: stroke, transient ischemic attack, systemic embolism, coronary spasm, myocardial infarction, cardiac tamponade, esophageal complications (atrio-esophageal and esophago-pericardial fistula or perforation), pulmonary vein stenosis, phrenic nerve injury with diaphragmatic paralysis persisting \> 6 months, vagal nerve injury, acute kidney injury, major bleeding, iatrogenic interatrial septal defect requiring closure, pericarditis, heart failure/pulmonary edema, and any device- or procedure-related death.
Time frame
From the index procedure up to 30 days post intervention.2
Percentage of monitored time spent in atrial fibrillation/atrial flutter/atrial tachycardia
Atrial arrhythmia burden will be calculated from insertable cardiac monitor data as the total duration of adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episodes divided by the total analyzable monitoring time, expressed as a percentage. Burden will be calculated from the end of the 2-month blanking period until the earliest of 12 months, cardioversion, repeat ablation, or protocol-defined antiarrhythmic drug use and through the full 12-month follow-up period in a complementary uncensored analysis.
Time frame
From the end of the 2-month blanking period through 12 months after ablation.3
Number of participants with an atrial fibrillation/atrial flutter/atrial tachycardia burden below 0.1%
Number of participants with insertable cardiac monitor-documented atrial fibrillation/atrial flutter/atrial tachycardia burden below 0.1%. Burden is defined as the total duration of adjudicated atrial arrhythmia episodes divided by the total analyzable monitoring time. In the primary analysis, participants undergoing cardioversion, repeat ablation, or protocol-defined antiarrhythmic drug treatment before 12 months will be classified as not achieving an arrhythmia burden below 0.1%.
Time frame
From the end of the 2-month blanking period through 12 months after ablation.4
Duration of the longest postablation atrial fibrillation/atrial flutter/atrial tachycardia episode
Duration of the longest adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episode recorded by the insertable cardiac monitor. The observation period will be censored at the first rhythm-altering intervention, defined as cardioversion, repeat ablation, or protocol-defined antiarrhythmic drug use.
Time frame
From the end of the 2-month blanking period until the earliest rhythm-altering intervention or 12 months after ablation.Sponsors and contacts
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Source ClinicalTrials.gov
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