A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF

Biosense Webster, Inc.50 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Pulsed Field Ablation SystemDEVICE

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (6)

AZORG campus Aalst Moorselbaan

Aalst, Belgium

RECRUITING

A.Z. Sint Jan

Bruges, Belgium

RECRUITING

Aarhus University Hospital

Aarhus N, Denmark

Outcomes

Primary Outcomes

Acute Procedural Success

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.

Time frame: Intraoperative

Pulmonary Vein Isolation (PVI) Durability

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.

Time frame: Up to 3 months post index ablation procedure

Pulsed Field (PF) Applications Time

PF applications time will be reported.

Time frame: Intraoperative

Number of PF applications

Number of PF applications will be reported.

Time frame: Intraoperative

Tissue Proximity Indication (TPI)

TPI will be reported.

Time frame: Intraoperative

Secondary Outcomes

Occurrence of Serious Adverse Device Effects (SADE) (Within Seven (7) days) of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan

A SADE is an adverse device effect that has resulted in any of the consequences characteristic of an serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

Central Contacts

Wannes Vermander

CONTACT

+32 494 03 08 40 wverman1@ITS.JNJ.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.