Atrial Fibrillation
Conditions
Keywords
Pulsed Field Ablation, Atrial Fibrillation
Brief summary
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.
Detailed description
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. Patients will undergo the standard catheter ablation procedure in accordance with good clinical practice, performing pulmonary vein islolation (PVI) with the FARAPULSE cardiac ablation system. In the control group PVI will be performed with 4 basket- and 4 flower-shaped applications of the catheter, while in the study group 2 olive-, 4 basket-, and 6 flower shaped applications will be delivered at each vein. All other procedural steps will be the same between groups. Patients will be randomized in a 1:1 fashion with a block size of 4 to the study arm or the usual care (control) arm. The primary study parameter for efficacy is the freedom of atrial arrhythmias after the 2-month blanking period up to 18 months after the procedure. The secondary study outcomes include the extent and position of pulmonary vein reconnection observed during redo procedures that are performed due to arrhythmia recurrence, which constitutes a study endpoint. Furthermore, the study also evaluates arrhythmia burden after the procedure in centers that routinely use photoplethysmographic remote monitoring as standard care for all their ablation patients.
Interventions
DEVICEPulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation
Standard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape
DEVICEPulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation
Experimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape
Sponsors
R&D Cardiologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Patients will be randomized in a 1:1 fashion with a block size of 4 to the study arm or the usual care (control) arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Left atrial appendage (LAA) closure in the past * Mechanical mitral valve * Non-adherence to oral anticoagulation in the 3 weeks prior to ablation * Renal disease with known eGFR\<45 ml * Left atrial volume index (LAVI) \>50 ml/m2 or left atrial diameter (LAD) \>50 mm * Known contra-indication for catheter ablation * Known contra-indication for deep sedation or general anesthesia * Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom of atrial fibrillation after a 2-month blanking period up to 18 months post procedure. | Baseline, month 3, month 6, month 12, month 18 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The potential for hemolysis in relation to application number | Post procedure every 24 hours, up to 5 days post procedure for each individual patient | 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 |
| The durability of pulmonary vein isolation in case of a redo procedure | Month 3, month 6, month 12, month 18. | 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 |
| Procedural-up-to-30 days and 30 days up-to 18 months safety of increasing PFA application numbers | From procedure to 18-month follow-up | 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 |
| Quality of life differences between groups | Baseline, month 3, month 6, month 12, month 18 | 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 |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORLucas VA Boersma, MD, PhD
St. Antonius Hospital
Outcome results
None listed