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NCT07527299 · Biosense Webster, Inc.

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

(SPAA PFA)

What this study is about

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease).

View original scientific description

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; PVI and SVCI), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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 severe dilatation of the LA (left atrial diameter \[LAD\] \> 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 (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 \[cm\^2\])
  • Participant has an implanted metal cardiac device (other than coronary stents, implanted pacemaker, implantable cardioverter-defibrillator \[ICD\], implantable loop recorder \[ILR\]) that may interfere with the pulsed field (PF) energy field
  • 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)

Where

  • Birmingham, Alabama
  • Tucson, Arizona
  • Fayetteville, Arkansas
  • Jonesboro, Arkansas
  • Larkspur, California
  • Newport, California
  • Santa Monica, California
  • Aurora, Colorado
  • Hartford, Connecticut
  • Atlantis, Florida
  • Jacksonville, Florida
  • Overland Park, Kansas

And 6 more locations — see the full list below.

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations

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1 of 920 participants interested
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See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

NOT_YET_RECRUITING

Birmingham

Alabama

Location available
WITHDRAWN

Tucson

Arizona

Location available
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Tucson

Arizona

Location available
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Fayetteville

Arkansas

Location available
RECRUITING

Jonesboro

Arkansas

Location available
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Larkspur

California

Location available
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Newport

California

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Santa Monica

California

Location available
NOT_YET_RECRUITING

Aurora

Colorado

Location available

And 10 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Atrial Fibrillation Trials by City

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Looking for Atrial Fibrillation Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Atrial Fibrillation Treatment Options in Birmingham, Alabama

If you're searching for Atrial Fibrillation treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Tucson, Fayetteville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Atrial Fibrillation. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 920 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Atrial Fibrillation?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Atrial Fibrillation

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Atrial Fibrillation Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07527299. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.