Atrial Fibrillation, Paroxysmal or PersistentVIRTUENCT06056557
Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
A study testing VARIPULSE™ catheter ablation in people with Atrial Fibrillation, Paroxysmal or Persistent and Atrial Fibrillation and Flutter, run by Vivek Reddy at 1 site in United States.
Trial summary
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal or Persistent, Atrial Fibrillation and Flutter, Atrial Flutter Typical
- What is being tested?
- VARIPULSE™ catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
- Previous surgical or catheter ablation for atrial fibrillation is allowed
- Planned for a catheter ablation procedure
- Able and willing to provide written consent and comply with all testing and follow-up requirements
- Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm
Who cannot join
- Documented "active" left atrial thrombus
- Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
- Previous PCI/MI within the past 1 month
- Active systemic infection or sepsis
- Uncontrolled heart failure - New York Heart Association (NYHA) function class IV.
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation.
Show all 10Show fewer
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.
Read the detailed description
By virtue of its efficiency, safety profile, and potential for improved efficacy in certain patient populations (e.g., thickened atrial tissue of hypertrophic cardiomyopathy (HCM) patients), there is tremendous excitement about the role of pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias. However, most PFA clinical trials enroll very selected populations and have highly focused inclusion/exclusion criteria - for example, typically only paroxysmal or persistent atrial fibrillation (AF) patients with upper age criteria are included, other disease states such as HCM are excluded, and typically redo ablation procedures are also excluded. The latter is particularly problematic since redo procedures are quite prevalent in most physicians' clinical practice.
In some sense, the incorporation of these restrictive criteria is not terribly surprising since most of the novel PFA catheters are specifically designed to perform only certain aspects of the AF ablation procedure (e.g., just PVI). That is, when there are more complex substrates (where other types of lesion sets may be needed), it may not be practical to allow a more inclusive criteria for enrollment. Of course, the downside is that the majority of the patients that are eventually treated in clinical practice are not reflected by the enrolled patient population.
The VARIPULSE™ catheter technology is a novel circular catheter with a variable loop design, containing multiple electrodes with individual irrigation pores capable of delivering pulse-field energy.
The Ablation procedure will follow the below sequence:
- Anatomical and voltage mapping of the left and/or right atrium
- To perform this mapping, the VARIPULSE bi-directional catheter or a compatible conventional FDA-approved multi-electrode mapping catheter (e.g., Pentaray, Octaray or Optrell) may be used
- Activation mapping of any-presenting or inducible atrial flutter
- Pulmonary Vein Isolation (PVI) to be achieved in all patients with atrial fibrillation (if not already achieved).
- Confirmation of entrance block with adenosine or isoproterenol challenge
- Additional ablation lesion sets are per the investigator's discretion including:
- Posterior wall Isolation
- Regional fractionation clusters
- Cavo-tricuspid isthmus Line
- Mitral Isthmus Line
- Any micro-/macro-reentrant atrial tachycardia's
- As part of the ablation procedure, any safety assessments that are considered important (e.g., EGD, coronary angiography, etc.) may be performed; these data will also be collected.
This study is a prospective, single-center, non-randomized, interventional clinical study to determine the safety and efficacy in using BWI IRE ablation system in a variety of atrial arrhythmias. Subjects will be followed for 12 months post-procedure.
- Conditions
- Atrial Fibrillation, Paroxysmal or Persistent, Atrial Fibrillation and Flutter, Atrial Flutter Typical
- Being tested
- VARIPULSE™ catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIPULSE™ catheter ablationDevice
Subjects will arrive to the electrophysiology laboratory for their ablation procedure and will undergo preparation for the procedure per standard protocol.
The purpose of an ablation procedure is to scar or destroy the heart tissue causing the atrial fibrillation. The current FDA approved ablation treatments commonly use freezing, radio frequency, or laser, delivered through a catheter that is threaded through blood vessels to the heart, as the energy source to destroy the abnormal tissue.
The BWI IRE VARIPULSE ablation system used in this study uses a type of energy source called pulse field.
Pulse field ablation applies ultra-rapid (less than 1 second) electrical fields to the heart muscle to destroy the abnormal tissue. This type of energy is thought to safer and more effective at treating atrial fibrillation.
● For a lesion set that cannot be performed using the VARIPULSE catheter technology, a conventional FDA-approved RF ablation
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All patients will receive the intervention. That is, all patients will undergo ablation with the experimental catheter (device). Receives: Device: VARIPULSE™ catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with acute procedural success
Acute procedural success is defined according to the type of arrhythmia, for example:
- Entrance block in all targeted PVs for patients treated for atrial fibrillation (Both first and Re-Do)
- Termination of atrial flutters for patients presenting in atrial flutter.
Measured: up to 12 months post-procedure
Secondary outcomes (11)
Percentage of time spent in atrial flutter/fibrillation/tachycardia
Percentage of time spent in atrial flutter/fibrillation/tachycardia as noted on CIED interrogation.
Measured: up to 12 months post-procedure
Percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration
The percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration as noted by implantable device after the 3-month blanking period until the end of 12 months of follow-up
Measured: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients presenting with persistent atrial fibrillation with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds
The percentage of patients presenting with persistent atrial fibrillation with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration as noted by implantable device after the 3-month blanking period until the end of 12 months of follow up in patients not taking anti-arrhythmic medications
Measured: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients who do not report recurrent of symptomatic arrhythmias
The percentage of patients who do not report recurrent of symptomatic arrhythmias as noted during telephone or office follow up after the 3-month blanking period until the end of 12 months of follow up
Measured: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds
The percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration as noted by implantable device after the 3-month blanking period until the end of 12 months of follow up in patients who are taking anti-arrhythmic medications
Measured: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients not taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration
The percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration as noted by implantable device after the 3-month blanking period until the end of 12 months of follow up in patients who not taking anti-arrhythmic medications
Measured: after 3-month blanking period until end of 12 months of follow-up
Durability of lesion sets in any patient that undergoes a second procedure
Durability of lesion sets in any patient that undergoes a second procedure (Block across attempted lines, absence of electrograms in targeted substrate) as measured with 3-d electroanatomic map to assess bidirectional block across ablation lines.
Measured: up to 12 months post-procedure
Number of patient emergency room (ER) visits
Number of patient emergency room (ER) visits
Measured: up to 12 months post-procedure
Number of patient Hospitalizations
Number of patient Hospitalizations
Measured: up to 12 months post-procedure
Number of patients requiring cardioversion
Measured by the actual occurrence of cardioversion procedures
Measured: up to 12 months post-procedure
Number of patients who experience repeat ablation
Number of patients who experience repeat ablation
Measured: up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start28 Sep 2023
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, Paroxysmal or PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, interventional clinical study to determine the safety and efficacy in using BWI IRE ablation system in a variety of atrial arrhythmias. All patients will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056557
- Sponsor's protocol ID
- STUDY-23-00978
- Acronym
- VIRTUE
- Status last verified
- Aug 2025
- First submitted
- 6 Sep 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data not available/not applicable.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
- ClinicalTrials.gov ID
- NCT06056557
- Acronym / sponsor ID
- VIRTUE / STUDY-23-00978
- Conditions
- Atrial Fibrillation, Paroxysmal or Persistent, Atrial Fibrillation and Flutter, Atrial Flutter Typical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.
Detailed description
By virtue of its efficiency, safety profile, and potential for improved efficacy in certain patient populations (e.g., thickened atrial tissue of hypertrophic cardiomyopathy (HCM) patients), there is tremendous excitement about the role of pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias. However, most PFA clinical trials enroll very selected populations and have highly focused inclusion/exclusion criteria - for example, typically only paroxysmal or persistent atrial fibrillation (AF) patients with upper age criteria are included, other disease states such as HCM are excluded, and typically redo ablation procedures are also excluded. The latter is particularly problematic since redo procedures are quite prevalent in most physicians' clinical practice.
In some sense, the incorporation of these restrictive criteria is not terribly surprising since most of the novel PFA catheters are specifically designed to perform only certain aspects of the AF ablation procedure (e.g., just PVI). That is, when there are more complex substrates (where other types of lesion sets may be needed), it may not be practical to allow a more inclusive criteria for enrollment. Of course, the downside is that the majority of the patients that are eventually treated in clinical practice are not reflected by the enrolled patient population.
The VARIPULSE™ catheter technology is a novel circular catheter with a variable loop design, containing multiple electrodes with individual irrigation pores capable of delivering pulse-field energy.
The Ablation procedure will follow the below sequence:
- Anatomical and voltage mapping of the left and/or right atrium
- To perform this mapping, the VARIPULSE bi-directional catheter or a compatible conventional FDA-approved multi-electrode mapping catheter (e.g., Pentaray, Octaray or Optrell) may be used
- Activation mapping of any-presenting or inducible atrial flutter
- Pulmonary Vein Isolation (PVI) to be achieved in all patients with atrial fibrillation (if not already achieved).
- Confirmation of entrance block with adenosine or isoproterenol challenge
- Additional ablation lesion sets are per the investigator's discretion including:
- Posterior wall Isolation
- Regional fractionation clusters
- Cavo-tricuspid isthmus Line
- Mitral Isthmus Line
- Any micro-/macro-reentrant atrial tachycardia's
- As part of the ablation procedure, any safety assessments that are considered important (e.g., EGD, coronary angiography, etc.) may be performed; these data will also be collected.
This study is a prospective, single-center, non-randomized, interventional clinical study to determine the safety and efficacy in using BWI IRE ablation system in a variety of atrial arrhythmias. Subjects will be followed for 12 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, interventional clinical study to determine the safety and efficacy in using BWI IRE ablation system in a variety of atrial arrhythmias. All patients will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: VARIPULSE™ catheter ablationAll patients will receive the intervention. That is, all patients will undergo ablation with the experimental catheter (device). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older.
- Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
- Previous surgical or catheter ablation for atrial fibrillation is allowed
- Planned for a catheter ablation procedure
- Able and willing to provide written consent and comply with all testing and follow-up requirements
Key exclusion criteria (10 listed)
- Documented "active" left atrial thrombus
- Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
- Previous PCI/MI within the past 1 month
- Active systemic infection or sepsis
- Uncontrolled heart failure - New York Heart Association (NYHA) function class IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VARIPULSE™ catheter ablationSubjects will arrive to the electrophysiology laboratory for their ablation procedure and will undergo preparation for the procedure per standard protocol. The purpose of an ablation procedure is to scar or destroy the heart tissue causing the atrial fibrillation. The current FDA approved ablation treatments commonly use freezing, radio frequency, or laser, delivered through a catheter that is threaded through blood vessels to the heart, as the energy source to destroy the abnormal tissue. The BWI IRE VARIPULSE ablation system used in this study uses a type of energy source called pulse field. Pulse field ablation applies ultra-rapid (less than 1 second) electrical fields to the heart muscle to destroy the abnormal tissue. This type of energy is thought to safer and more effective at treating atrial fibrillation. ● For a lesion set that cannot be performed using the VARIPULSE catheter technology, a conventional FDA-approved RF ablation | Device | Interventional |
Primary outcome
Number of participants with acute procedural success
Time frame: up to 12 months post-procedure
Acute procedural success is defined according to the type of arrhythmia, for example: * Entrance block in all targeted PVs for patients treated for atrial fibrillation (Both first and Re-Do) * Termination of atrial flutters for patients presenting in atrial flutter.
11 secondary outcomes
Percentage of time spent in atrial flutter/fibrillation/tachycardia
Time frame: up to 12 months post-procedure
Percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration
Time frame: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients presenting with persistent atrial fibrillation with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds
Time frame: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients who do not report recurrent of symptomatic arrhythmias
Time frame: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds
Time frame: after 3-month blanking period until end of 12 months of follow-up
Percentage of patients not taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration
Time frame: after 3-month blanking period until end of 12 months of follow-up
Durability of lesion sets in any patient that undergoes a second procedure
Time frame: up to 12 months post-procedure
Number of patient emergency room (ER) visits
Time frame: up to 12 months post-procedure
Number of patient Hospitalizations
Time frame: up to 12 months post-procedure
Number of patients requiring cardioversion
Time frame: up to 12 months post-procedure
Number of patients who experience repeat ablation
Time frame: up to 12 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No. Data not available/not applicable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VARIPULSE™ catheter ablation in people with Atrial Fibrillation, Paroxysmal or Persistent and Atrial Fibrillation and Flutter, run by Vivek Reddy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute procedural success (time frame: up to 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.