NCT07523750Recruiting
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 566 (estimated)
- First submitted
- 6 Apr 2026
- Start date
- 2 Apr 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07523750
What you commit to
- Study type: Interventional
- Planned participants: 566
- From 2 Apr 2026 to the primary completion date, 31 May 2028
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has had previous surgical or catheter ablation for AF
- Participant has severe dilatation of the LA (LAD \> 50 millimeters \[mm\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
- Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
- Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
- Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
- Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
- Participant has unstable angina within past 6 months prior to enrollment
- Participant is currently enrolled in an investigational study evaluating another device or drug
Other illness
- Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
- Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
- Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
- Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
- Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Participant has an acute illness, active systemic infection, or sepsis
- Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \[ILR\])
- Participant has a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter)
- Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera
Lab values
- Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \[\<\] 40%) confirmed by imaging performed within 180 days prior to enrollment
Other
- Participant has continuous AF \> 365 days (longstanding persistent AF)
- Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
- Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
- Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
- Participant has a pre-existing hemi-diaphragmatic paralysis
- Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \[\>=\] 60 milliliters \[mL\]/beat, regurgitant fraction \>= 50 percent \[%\], and/or effective regurgitant orifice area \>= 0.40 square centimeter \[cm\^2\])
- Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
- Participant has a life expectancy less than 365 days
- For magnetic resonance imaging (MRI) subset:
- Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI
- Unresolved pre-existing neurological deficit
Who the study is looking for
- Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \[\>\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
- Participant is aged 18 - 80 years at the time of informed consent
- Participant is willing and capable of providing informed consent
- Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| OC Medical Center Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| St. Vincents Medical Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Arrhythmia Research Group Coordinator of this site? Confirm its status | Jonesboro | United States | Recruiting |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| HCA Florida Mercy Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| NCH Healthcare Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Rutgers, Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Baylor Research Institute Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| WakeMed Hospital Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Rochester General Hospital Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Community Memorial Hospital Coordinator of this site? Confirm its status | Ventura | United States | Recruiting |
| Trinity Health Michigan Heart - Ann Arbor Campus Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.