A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

Official title

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

Overview

The main purpose of this clinical study is to investigate the effectiveness 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 paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year 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 Effectiveness [Time frame: Intraoperative]
• Pulmonary Vein Isolation (PVI) Durability [Time frame: At 3 months post index ablation procedure]
• Pulsed Field (PF) Application Time [Time frame: Intraoperative]
• Number of PF applications by PV [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: 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: Up to 3 months post index ablation procedure]
• Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations [Time frame: Up to 3 months post index ablation procedure]
• Occurrence of New or Worsening Neurological Deficits [Time frame: Up to 3 months post index ablation procedure]
• Mini Mental State Examination (MMSE) [Time frame: Baseline up to 3 months post index ablation procedure]
• National Institutes of Health Stroke Scale (NIHSS) [Time frame: Baseline up to 3 months post index ablation procedure]
• Modified Rankin Scale (mRS) [Time frame: Baseline up to 3 months post index 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) or paroxysmal atrial fibrillation (PAF)
• Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
• 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 millimeters \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
• Severely compromised left ventricular ejection fraction (LVEF less than \[<\] 40 percent \[%\])
• 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)
• Myocardial infarction (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 \[Body Mass Index >40 kilogram per meter square {kg/m\^2}\], renal insufficiency (with an estimated creatinine clearance < 30 milliliters per minute {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 instructions 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 principal investigator \[PI\] 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: NCT07429214 · BWI202525 · BWI202525

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗