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

Official title

Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software

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)

Interventions

• Device Pulsed Field Ablation System
  Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used.

Primary outcome measures

• Acute Procedural Success [Time frame: Intraoperative]
• Pulmonary Vein Isolation (PVI) Durability [Time frame: Up to 3 months post index ablation procedure]
• Pulsed Field (PF) Applications Time [Time frame: Intraoperative]
• Number of PF applications [Time frame: Intraoperative]
• Tissue Proximity Indication (TPI) [Time frame: Intraoperative]

Secondary outcome measures (12)

• 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 [Time frame: Up to 7 days post index ablation procedure]
• Occurrence of Unanticipated Serious Adverse Device Effects (USADEs) [Time frame: Up to 3 months post index ablation procedure]
• Occurrence of SAEs [Time frame: At 7 days, 8 to 30 days (peri-procedural) and up to 3 months post index ablation procedure]
• Occurrence of Non-Serious Adverse Events (Non-SAEs) [Time frame: Up to 3 months post index ablation procedure]
• Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations [Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure]
• Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations [Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure]
• Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations [Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure]
• Occurrence of New or Worsening Neurological Deficits [Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure]
• Mini Mental State Examination (MMSE) Total Score [Time frame: Baseline (within 72 hours prior to ablation), and post-ablation (72 hours after ablation procedure)]
• National Institutes of Health Stroke Scale (NIHSS) Score [Time frame: Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure)]
• Modified Rankin Scale (mRS) Scale Score [Time frame: Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure)]
• Occurrence of Severe Pulmonary Vein (PV) Stenosis [Time frame: Up to 3 months post index ablation procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 2 centers

• AZORG campus Aalst Moorselbaan — Aalst
• A.Z. Sint Jan — Bruges

France · 2 centers

• Hospices Civils de Lyon HCL — Bron
• Institut Medico chirurgical Montsouris — Paris

Italy · 2 centers

• Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata' — Roma
• IRCCS Policlinico San Donato — San Donato Milanese

Denmark · 1 center

• Aarhus University Hospital — Aarhus N

Germany · 1 center

• University Hospital of the Ruhr-University of Bochum — Bad Oeynhausen

Lithuania · 1 center

• Vilnius University Hospital Santaros Clinics — Vilnius

Netherlands · 1 center

• Erasmus MC — Rotterdam

Identifiers

NCT: NCT07428564 · BWI202513 · BWI202513

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗