Actively Recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Led by Biosense Webster, Inc. · Updated on 2026-05-11
50
Participants Needed
10
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 managing 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) due to recurrent symptoms or intolerance
- Age between 18 and 75 years
- Willing and able to give consent
- Able and willing to follow all pre-, post-, and follow-up testing and requirements
You will not qualify if you...
- Continuous atrial fibrillation lasting more than 12 months (longstanding persistent AF)
- Previous surgical or catheter ablation for atrial fibrillation
- Cardiac surgery or percutaneous coronary intervention within 2 months before consent
- Previous coronary artery bypass grafting with valvular or cardiac surgery
- Any carotid stenting or endarterectomy
- Presence of left atrial thrombus
- Severe left atrial enlargement (diameter over 50 mm by echocardiography)
- Severely reduced left ventricular ejection fraction (less than 40%)
- Significant pulmonary vein anomalies or prior pulmonary vein stenosis
- Pre-existing half-diaphragm paralysis
- History of blood clotting or bleeding problems or inability to take anticoagulants
- Myocardial infarction within past 2 months
- Thromboembolic event within past 6 months
- Rheumatic heart disease
- Uncontrolled heart failure (NYHA class III or IV)
- Severe mitral valve leakage
- Planned cardiac transplant, surgery, or major surgery within next 12 months
- Unstable angina within past 6 months
- Acute illness, infection, or sepsis
- Atrial fibrillation caused by reversible or non-cardiac causes like electrolyte imbalance or thyroid disease
- Conditions preventing catheter use or vascular access
- Significant lung disease causing chronic symptoms
- Significant congenital or medical problems preventing participation
- Women who are pregnant, lactating, or planning pregnancy during study
- Current participation in another investigational study
- Contraindications to device use
- Vulnerable populations needing special safeguards
- Life expectancy less than 12 months
- Contraindications for MRI
- Presence of iron-containing metal fragments
- Unresolved neurological deficits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
AZORG campus Aalst Moorselbaan
Aalst, Belgium, 9300
Not Yet Recruiting
2
A.Z. Sint Jan
Bruges, Belgium, 8000
Not Yet Recruiting
3
Aarhus University Hospital
Aarhus N, Denmark, 8200
Not Yet Recruiting
4
Hospices Civils de Lyon HCL
Bron, France, 69500
Not Yet Recruiting
5
Institut Medico chirurgical Montsouris
Paris, France, 75014
Not Yet Recruiting
6
University Hospital of the Ruhr-University of Bochum
Bad Oeynhausen, Germany, 32545
Not Yet Recruiting
7
Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
Roma, Italy, 00133
Not Yet Recruiting
8
IRCCS Policlinico San Donato
San Donato Milanese, Italy, 20097
Not Yet Recruiting
9
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania, 08406
Actively Recruiting
10
Erasmus MC
Rotterdam, Netherlands, 3015
Not Yet Recruiting
Research Team
N
Nathalie Macours
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here