Image

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

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

Recruiting
18-75 years
All
Phase N/A

Powered by AI

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 paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Eligibility

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 etc. (at principal investigator \[PI\] discretion)
  • Presence of iron-containing metal fragments in the body
  • Unresolved pre-existing neurological deficit

Study details
    Atrial Fibrillation

NCT07429214

Biosense Webster, Inc.

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.