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New treatment option for Atrial Fibrillation
Official title A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
ClinicalTrials.gov ID: NCT07429214
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or...
- Age 18-75 years
- Willing and capable of providing consent
You likely can't join if
- 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...
- Any carotid stenting or endarterectomy
- Presence of left atrium (LA) thrombus
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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 millimeters [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
- Severely compromised left ventricular ejection fraction (LVEF less than [\<] 40 percent [%])
- 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)
- 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])
- 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...
- 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...
- 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 instructions 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 principal investigator [PI]...
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Bruges, Belgium
- Aarhus N, Denmark
- Bron, France
- Paris, France
- Bad Oeynhausen, Germany
- Roma, Italy
- San Donato Milanese, Italy
- Vilnius, Lithuania
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Bruges, Belgium; Aarhus N, Denmark; Bron, France; Paris, France; Bad Oeynhausen, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.