Actively Recruiting
Effectiveness Study of VARIPULSE Catheter and TRUPULSE Generator Using VARIPULSE Pro Software to Treat Paroxysmal and Persistent Atrial Fibrillation
Led by Biosense Webster, Inc. · Updated on 2026-07-13
50
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the pulsed field ablation system, which includes the VARIPULSE Catheter, TRUPULSE Generator, and the new VARIPULSE Pro software, for treating participants with paroxysmal atrial fibrillation PAF and persistent atrial fibrillation PsAF. The study focuses on the workflow effectiveness of this system during cardiac ablation procedures aimed at managing irregular heartbeats in these populations. Participants will undergo pulsed field ablation PFA using the VARIPULSE Catheter and TRUPULSE Generator with the VARIPULSE Pro software. The study involves a single group receiving this device-based intervention to treat symptomatic PsAF or PAF through pulmonary vein isolation PVI alone or combined with cavotricuspid isthmus-dependent atrial flutter ablation. The treatment is delivered during an ablation procedure with the device system. During the study, participants will be monitored for various outcomes including acute effectiveness during the procedure, durability of pulmonary vein isolation at 3 months, and procedural details such as pulsed field application time and number of applications. Safety assessments include monitoring for serious and non-serious adverse events up to 3 months post-procedure, neurological evaluations using MRI and cognitive scales, and assessment of pulmonary vein stenosis. The total participation duration extends at least 3 months post ablation for follow-up and outcome measurement.
CONDITIONS
Brief Title
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)
- Selected for ablation procedure for management of arrhythmia by pulmonary vein isolation (PVI) only or PVI with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
- Failed at least one antiarrhythmic drug (class I to IV) or intolerant/contraindicated to such drugs
- Age between 18 and 75 years
- Willing and able to provide consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You will not qualify if you...
- Continuous atrial fibrillation longer than 12 months (longstanding persistent AF)
- Previous surgical or catheter ablation for atrial fibrillation
- Cardiac surgery within 2 months prior to consent (including percutaneous coronary intervention)
- Previous coronary artery bypass grafting with valvular or cardiac surgery procedures
- Any carotid stenting or endarterectomy
- Presence of left atrium thrombus
- Severe left atrial dilation (diameter >50 mm by transthoracic echocardiography)
- Severely compromised left ventricular ejection fraction (less than 40%)
- Known significant pulmonary vein anomaly preventing enrollment
- Prior diagnosis of pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- History of blood clotting or bleeding disorders or contraindication to anticoagulation
- Myocardial infarction within 2 months prior to consent
- Documented thromboembolic event within 6 months prior to consent
- Rheumatic heart disease
- Uncontrolled heart failure or NYHA class III or IV
- Severe mitral regurgitation
- Planned cardiac transplantation, surgery, or major surgery within 12 months
- Unstable angina within 6 months prior to consent
- Acute illness or active systemic infection or sepsis
- AF secondary to reversible or non-cardiac causes such as electrolyte imbalance, thyroid disease, obstructive sleep apnea, acute alcohol toxicity, morbid obesity (BMI >40), or renal insufficiency
- Presence of intracardiac thrombus, tumor, prosthetic valve, or other abnormalities preventing catheter use
- Presence of intramural thrombus or vascular access abnormalities
- Significant pulmonary disease including restrictive, constrictive, or COPD
- Significant congenital anomaly or medical problems preventing enrollment
- Women who are pregnant, lactating, or planning pregnancy during the study
- Current enrollment in another investigational study
- Contraindications for study devices
- Vulnerable populations requiring special safeguards
- Life expectancy less than 12 months
- Contraindication for MRI such as advanced renal disease, claustrophobia, implantable devices
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit
Research Team
N
Nathalie Macours
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