New heart procedure tested against leading device for AFib control
NCT ID NCT07523750
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 5 times
Summary
This study tests a new catheter called VARIPULSE against an already approved one, FARAWAVE, for people with persistent atrial fibrillation (a long-lasting irregular heartbeat). About 466 participants will receive one of the two treatments to see which is safer and better at restoring normal heart rhythm. The goal is to control the condition and improve quality of life, not to cure it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 566 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * 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 Exclusion criteria: * Participant has continuous AF \> 365 days (longstanding persistent AF) * 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 had previous surgical or catheter ablation for 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 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 severely compromised Left Ventricular Ejection Fraction (LVEF less than \[\<\] 40%) confirmed by imaging performed within 180 days prior to enrollment * 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 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 had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve) * Participant has unstable angina within past 6 months prior to enrollment * 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 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 acute illness, active systemic infection, or sepsis * 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 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) * Participant is currently enrolled in an investigational study evaluating another device or drug * 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: * Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera * Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI * Unresolved pre-existing neurological deficit
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arrhythmia Research Group
RECRUITINGJonesboro, Arkansas, 72401, United States
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Baylor Research Institute
RECRUITINGPlano, Texas, 75093, United States
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Community Memorial Hospital
RECRUITINGVentura, California, 93003, United States
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Intermountain Medical Center
RECRUITINGMurray, Utah, 84107, United States
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Lenox Hill Hospital
RECRUITINGNew York, New York, 10075, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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NCH Healthcare
RECRUITINGNaples, Florida, 34102, United States
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OC Medical Center
RECRUITINGFountain Valley, California, 92708, United States
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Texas Cardiac Arrhythmia Research Foundation
RECRUITINGAustin, Texas, 78705, United States
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WakeMed Hospital
RECRUITINGRaleigh, North Carolina, 27610, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise tame atrial fibrillation? trial tests workouts on heart rhythm and fitness
- Pacemaker lead position may cut heart rhythm complication
- Can zapping the heart beat drugs for AF in heart failure?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation