Pulsed Field Ablation System: Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used.
Study summary
The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion criteria:
* Diagnosed with symptomatic persistent atrial fibrillation (PsAF)
* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) +
* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
* Age 18-75 years
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion criteria:
* Continuous AF greater than (\>) 12 months (1-Year) (Longstanding Persistent AF)
* Previous surgical or catheter ablation for atrial fibrillation
* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \[PCI\])
* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
* Any carotid stenting or endarterectomy
* Presence of left atrium (LA) thrombus
* Severe dilatation of the LA (left atrial diameter (LAD) \> 50 millimeter \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
* Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40%)
* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
* Prior diagnosis of pulmonary vein stenosis
* Pre-existing hemi diaphragmatic paralysis
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* MI within the past 2 months (60 days prior to consent date)
* Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 6 months (180 days prior to consent date)
* Rheumatic Heart Disease
* Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
* Severe mitral regurgitation
* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
* Unstable angina pectoris within the past 6 months prior to consent date
* Acute illness or active systemic infection or sepsis
* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity (Body Mass Index \>40 kilogram per meter squared \[kg/m\^2\]), renal insufficiency (with an estimated creatinine clearance \< 30 mL/min/1.73 m\^2)
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation
* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
* Presence of any other condition that precludes appropriate vascular access (such as Inferior Vena Cava \[IVC\] filter)
* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \[COPD\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation.
* Current enrollment in an investigational study evaluating another device, biologic, or drug
* Presenting contra-indications for the devices used in the study, as indicated in the respective instruction for use (IFU)
* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
* Life expectancy less than 12 months
* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter/defibrillators (ICDs),etc. (at PI discretion)
* Presence of iron-containing metal fragments in the body
* Unresolved pre-existing neurological deficit
Primary outcome measure(s)
Acute Procedural Success — Intraoperative Acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported.
Pulmonary Vein Isolation (PVI) Durability — Up to 3 months post index ablation procedure PVI durability is defined as sustained isolation of PVs that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 days (+/- 14 days) post index ablation procedure.
Pulsed Field (PF) Applications Time — Intraoperative PF applications time will be reported.
Number of PF applications — Intraoperative Number of PF applications will be reported.
Tissue Proximity Indication (TPI) — Intraoperative TPI will be reported.
Trial sites (6)
Facility
City
Region
Status
AZORG campus Aalst Moorselbaan
Aalst
Belgium
Recruiting
A.Z. Sint Jan
Bruges
Belgium
Recruiting
Aarhus University Hospital
Aarhus N
Denmark
Recruiting
University Hospital of the Ruhr-University of Bochum
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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