VARIPULSE Catheter Ablation for Atrial Fibrillation

(VIRTUE Trial)

Overseen By Betsy Ellsworth, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivek Reddy

Disqualifiers: Active thrombus, Recent PCI/MI, Infection, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the VARIPULSE catheter, to treat atrial fibrillation, a condition where the heart beats irregularly. The researchers aim to determine if this device is safe and effective when used with the TRUPULSE™ Generator and a 3D mapping system during ablation procedures. It targets individuals diagnosed with atrial fibrillation or a related heartbeat issue who have already planned to undergo an ablation procedure. Participants should be prepared for follow-up and either have or be acquiring a heart rhythm monitoring device. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatments for heart rhythm issues.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VARIPULSE catheter technology is safe for treating atrial fibrillation?

Research has shown that the VARIPULSE catheter ablation for atrial fibrillation is very safe. In earlier studies, no deaths, strokes, or heart-related hospital visits were reported, indicating that the treatment did not cause serious problems for patients. One study found the VARIPULSE system to be 99.7% effective, with no strokes occurring in nearly 800 patients. Another study reported no major adverse events, meaning no serious side effects were noted. Overall, these findings suggest that the VARIPULSE catheter ablation is well-tolerated and has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for atrial fibrillation, like radiofrequency or cryoablation, work by using heat or extreme cold to destroy problematic heart tissue. But the VARIPULSE™ catheter ablation is unique because it utilizes a novel device that delivers targeted energy in a different way. Researchers are excited about this because it might offer more precise ablation with potentially fewer side effects or complications. This could lead to a safer and more effective way to restore normal heart rhythm in patients with atrial fibrillation.

What evidence suggests that the VARIPULSE catheter ablation is effective for atrial fibrillation?

Studies have shown that the VARIPULSE catheter ablation effectively treats atrial fibrillation. In one study, the treatment succeeded in about three-quarters of the patients, with a success rate of 75.6%. Another study found that the VARIPULSE Platform was effective in nearly all cases, achieving a 99.7% success rate immediately after the procedure. Additionally, one year later, 63.5% of patients remained free from atrial fibrillation. These results suggest that the VARIPULSE catheter technology can effectively manage atrial fibrillation. All participants in this trial will receive the VARIPULSE catheter ablation as the sole intervention. ^{3 5 6 7 8}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Adults diagnosed with atrial fibrillation or atypical atrial flutter, who are planning a catheter ablation procedure and can follow the study's requirements. Those with previous ablations for atrial fibrillation may join. Exclusions include active heart infections, recent heart attacks, severe heart failure, clotting issues, pregnant women, and those in other conflicting studies.

Inclusion Criteria

I have been diagnosed with atrial fibrillation or atypical atrial flutter.

Able and willing to provide written consent and comply with all testing and follow-up requirements

I have or will get a device implanted to monitor my heart rhythm.

Exclusion Criteria

I do not have heart conditions that prevent catheter use, like clots or tumors.

I had a heart attack or a procedure to open my heart's arteries within the last month.

I do not have an ongoing serious infection or sepsis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablation Procedure

Participants undergo anatomical and voltage mapping, activation mapping, and pulmonary vein isolation using the VARIPULSE catheter technology.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ablation procedure, with assessments including emergency room visits, cardioversion, and arrhythmia recurrence.

12 months

Regular follow-up visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• VARIPULSE™ catheter ablation

Trial Overview The trial is testing the VARIPULSE catheter used with TRUPULSE Generator and Carto 3D system to treat atrial fibrillation/flutter during standard ablation procedures. It aims to assess safety and effectiveness of this technology combination.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

All patients will receive the intervention. That is, all patients will undergo ablation with the experimental catheter (device).

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Recruited

5,700+

Citations

1. jnjmedtech.com jnjmedtech.com/en-US/inspire-study-varipulse-catheter

inspIRE Study (VARIPULSE Catheter) | Biosense Webster The primary effectiveness endpoint was 75.6% (95% CI 69.5% to 81.8%) for the full per-protocol cohort;b therefore, the primary effectiveness endpoint was met ( ...

2. jnj.com jnj.com/media-center/press-releases/johnson-johnson-unveils-results-from-the-varipure-substudy-of-secure-a-real-world-study-on-varipulse-platform-at-2025-european-society-of-cardiology-esc-congress

VARIPURE demonstrated strong safety outcomes with ... VARIPURE demonstrated strong safety outcomes with no incidence of stroke and 99.7% acute effectiveness of the VARIPULSE™ Platform in nearly ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1547527125029261

Patient-reported outcomes of deep sedation during pulsed ... At 6-month follow-up, arrhythmia recurrence occurred in 11.5% of patients, with six requiring cardioversion and one repeat ablation. No sedation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12245927/

Near-zero fluoroscopy workflow for pulmonary vein ... Catheter ablation is as a widely accepted and effective treatment for atrial fibrillation (AF), providing better outcomes for maintaining sinus ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02980-7/fulltext

Low acute complication rates with a variable loop pulsed ... No deaths, strokes, cardiac tamponade, or device-related hospitalizations were reported. This early real-world experience with the VLCC ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240006B.pdf

Summary of Safety and Effectiveness Data (SSED) The VARIPULSE Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1547527125029807

Low Acute Complication Rates with a Variable Loop ... No deaths, strokes, cardiac tamponade, or device-related hospitalizations were reported. This early real-world experience with the VLCC ...