New heart device aims to tame persistent AFib
NCT ID NCT07527299
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study is testing a new device called the VARIPULSE catheter system to treat persistent atrial fibrillation, a type of irregular heartbeat. The device uses pulsed field ablation to isolate specific heart veins and may be combined with a procedure to close off a heart pouch to reduce stroke risk. About 920 participants will be followed to see if the treatment is safe and effective over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VARIPULSE catheter system (pulsed field ablation device)
- What this could lead to
- If successful, this could provide a safer and more effective way to control persistent atrial fibrillation, reducing symptoms and stroke risk.
- What could go wrong
- This is an early-stage trial with 920 participants, so results may not apply to everyone. Risks include serious complications like stroke, heart damage, or nerve injury.
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 1,070 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
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 in duration 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 (ECGs) 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 requirement Left atrial appendage occlusion (LAAO) concomitant subset: \- Participant is clinically indicated for a LAAO procedure 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 LA (left atrial) anteroposterior \>= 55 millimeter (mm) (by magnetic resonance imaging \[MRI\], computed tomography \[CT\], or transthoracic echocardiogram \[TTE\]), or if LA diameter is not available, non-index volume \>100 milliliter (mL) confirmed within 365 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 (left ventricle ejection fraction \[LVEF\] less than \[\<\] 40 percent \[%\]) 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 functional classification * Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin) * Participant has had a thromboembolic event (including transient ischemic attack \[TIA\]) within the past 180 days prior to enrollment * Participant has had a percutaneous coronary intervention or acute myocardial infarction (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 (that is, 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%, and/or Effective regurgitant orifice area \>= 0.40 square centimeter \[cm\^2\]) * Participants with an implanted metal cardiac device that may interfere with the pulsed field energy field are excluded, including but not limited to: -MitraClip, -LAAO devices (for example, WATCHMAN, Amulet), -Double-coiled implantable cardioverter-defibrillators (ICDs). This exclusion does not apply to participants with any of the following devices: -Coronary stents, -Implanted pacemakers, -Single-coiled ICDs, -Implantable loop recorders (ILRs) * 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 of less than 365 days * Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs) * Participant has contraindications for the ablation of the SVC LAAO concomitant subset: * Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device * Participant with prior LAAO procedure (attempted or successful)
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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
3 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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Albert Einstein College Of Medicine - Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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Arrhythmia Research Group
RECRUITINGJonesboro, Arkansas, 72401, United States
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Pima Heart and Vascular
RECRUITINGTucson, Arizona, 85741, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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