NCT07429214Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 18 Feb 2026
- Start date
- 23 Mar 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07429214
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 23 Mar 2026 to the primary completion date, 30 Dec 2026
- 6 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior diagnosis of pulmonary vein stenosis
- 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 \[180 days prior to consent date\])
- Unstable angina pectoris within the past 6 months prior to consent date
- Current enrollment in an investigational study evaluating another device, biologic, or drug
- Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
Other illness
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Rheumatic Heart Disease
- Uncontrolled heart failure or New York heart association (NYHA) function class III or IV
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- Acute illness or active systemic infection or sepsis
- 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
- 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)
Lab values
- Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\])
- 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)
Age
- 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
Other
- Continuous AF greater than (\>) 12 months (1-Year) (Longstanding Persistent AF)
- 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 \[TTE\])
- Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
- Pre-existing hemi diaphragmatic paralysis
- Severe mitral regurgitation
- 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
- Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study
- Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)
- Life expectancy less than 12 months
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZORG Campus Aalst-Moorselbaan Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| A.Z. Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| University Hospital of the Ruhr-University of Bochum Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| IRCCS Policlinico San Donato Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Unknown status |
| Vilnius University Hospital Santaros Clinics Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.