New heart tool aims to simplify AFib treatment
NCT ID NCT07428564
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This study tests a new system (VARIPULSE catheter and TRUPULSE generator) with updated software for treating persistent atrial fibrillation, a long-lasting irregular heartbeat. About 50 adults aged 18-75 who have not responded to medication will undergo a heart ablation procedure. The main goal is to see how well the system works in practice, measuring procedure times and effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.Z. Sint Jan
RECRUITINGBruges, 8000, Belgium
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AZORG campus Aalst Moorselbaan
RECRUITINGAalst, 9300, Belgium
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Aarhus University Hospital
RECRUITINGAarhus N, 8200, Denmark
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IRCCS Policlinico San Donato
RECRUITINGSan Donato Milanese, 20097, Italy
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Vilnius University Hospital Santaros Clinics
RECRUITINGVilnius, 08406, Lithuania
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Other studies related to the condition(s) this trial covers.
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