Actively Recruiting
Workflow Study of the VARIPULSE Catheter with the TRUPULSE Generator for Treatment of Paroxysmal or Persistent Atrial Fibrillation Using the New VARIPULSE Pro Software
Led by Biosense Webster, Inc. · Updated on 2026-05-11
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 and workflow of the pulsed field (PF) ablation system, including the VARIPULSE catheter, TRUPULSE generator, and new VARIPULSE Pro software, in participants with paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PsAF). These heart rhythm disorders involve irregular heartbeats of varying durations, and the study aims to better understand the clinical use of this device setup for cardiac ablation. The study is interventional and sponsored by Biosense Webster, Inc. Participants will undergo cardiac ablation using the pulsed field ablation system with the VARIPULSE catheter and TRUPULSE generator combined with the VARIPULSE Pro software. This procedure targets pulmonary vein isolation (PVI) and may include cavotricuspid isthmus (CTI) dependent atrial flutter ablation. The study focuses on the ablation procedure workflow and device application during the treatment of symptomatic PAF or PsAF. Throughout the study, researchers will measure outcomes such as total procedure time, pulsed field application time, number of applications at different heart locations, pulmonary vein isolation time, fluoroscopy time, catheter dwell time, and acute effectiveness during the procedure. Safety outcomes include monitoring for serious and non-serious adverse device effects up to three months after the procedure. Participants will need to comply with all pre-, post-, and follow-up assessments, including testing and clinical evaluations, during the study period.
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 to undergo ablation procedure for arrhythmia management 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 provide informed consent
- Able and willing to comply with all pre-, post-, and follow-up testing and study requirements
You will not qualify if you...
- Continuous atrial fibrillation lasting longer than 12 months (longstanding persistent AF)
- Previous surgical or catheter ablation for atrial fibrillation
- Cardiac surgery or percutaneous coronary intervention within 60 days before consent
- Previous coronary artery bypass grafting with valvular surgery or other cardiac surgery
- Carotid stenting or endarterectomy
- Presence of left atrium thrombus
- Severe left atrial dilation (diameter >50 mm by transthoracic echocardiography)
- Severely reduced left ventricular ejection fraction (<40%)
- Significant pulmonary vein anomalies or prior pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- History of blood clotting or bleeding disorders or contraindication to anticoagulation
- Myocardial infarction within 60 days prior to consent
- Documented thromboembolic event within 6 months prior to consent
- Rheumatic heart disease
- Uncontrolled heart failure (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, infection, or sepsis
- Atrial fibrillation due to reversible or non-cardiac causes
- Cardiac structural abnormalities preventing catheter use
- Conditions precluding vascular access or catheter manipulation
- Significant pulmonary or respiratory disease causing chronic symptoms
- Significant congenital anomalies or medical problems precluding enrollment
- Pregnancy, lactation, or planning pregnancy during study
- Current enrollment in another investigational trial
- Contraindications for the study devices
- Vulnerable populations needing special safeguards
- Life expectancy less than 12 months
- Contraindications for MRI or presence of iron-containing metal fragments
- Unresolved neurological deficits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo pulsed field ablation using the VARIPULSE Catheter and TRUPULSE Generator with VARIPULSE Pro software to treat atrial fibrillation.
1 procedure visit (in-person)
Duration - Up to 3 months
Participants are monitored for safety and effectiveness following the ablation procedure.
Multiple follow-up visits over 3 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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