Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorR&D Cardiologie
About this trial
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND
Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
Disqualifiers
Cerebrovascular accident (CVA) in the last 6 months
More than moderate valvular disease that would require intervention
Cardiac catheter/surgical intervention in the last 3 months or scheduled
Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation
DeviceStandard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape
Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation
DeviceExperimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape
Treatment groups
378 Participants
are divided into 2 treatment groupsGroup A: Experimental arm, extra applicationsExperimental treatment 1 intervention
Group B: Control arm, standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Freedom of atrial fibrillation after a 2-month blanking period up to 18 months post procedure.
The primary efficacy outcome will be the freedom of arrhythmias lasting \>30 seconds after a single PVI ablation procedure from the blanking period of 2 months until 18 months follow-up after ablation. Any left-sided ablation procedure after a successful index procedure will count as treatment failure. An atrioventricular (nodal) reentry tachycardia (AVNRT/AVRT), or typical right atrial flutter occurring after the index procedure, will not count as treatment failure.
Time frame
Baseline, month 3, month 6, month 12, month 18Secondary outcomes
1
Procedural-up-to-30 days and 30 days up-to 18 months safety of increasing PFA application numbers
Compare the number of major adverse event between both study arms including (but not exclusively) cardiac tamponade, clinically relevant pulmonary vein stenosis, atrio-esophageal fistula, stroke, persisting phrenic nerve palsy, major bleeding (BARC criteria), hemolysis, cardiac arrest, death
Time frame
From procedure to 18-month follow-up2
Quality of life differences between groups
QOL will be assessed with the Atrial Fibrillation Quality of Life Questionaire scoring system asking 18 question with a score on a scale of 1-7 and a range of 0-100. This will be compared between both study arms
Time frame
Baseline, month 3, month 6, month 12, month 183
The potential for hemolysis in relation to application number
Hemolysis will be assessed by testing urine-samples with hemosticks based on the grading system of the urine stick. In case of a positive urine-stick patients will undergo further diagnostic testing by blood test to determine severity of hemolysis. The number patients with hemolysis and the severity of hemolysis between the study arms will be evaluated
Time frame
Post procedure every 24 hours, up to 5 days post procedure for each individual patient4
The durability of pulmonary vein isolation in case of a redo procedure
Mapping of the electrical activity of each pulmonary vein will performed in each patient undergoing a repeat ablation procedure. The number and pattern of electrical reconnection will be compared between both study arms
Time frame
Month 3, month 6, month 12, month 18.Sponsors and contacts
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Source ClinicalTrials.gov