VARIPULSE Catheter System for Atrial Fibrillation

(AdmIREPAS Trial)

Recruiting at 2 trial locations

Overseen By Emily Purcell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Disqualifiers: Persistent AF, Previous ablation, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

276 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the VARIPULSE catheter system to determine its safety and effectiveness as a long-term treatment for paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat that comes and goes. The study focuses on using this system for pulmonary vein isolation, targeting the veins that cause irregular heartbeats. Researchers seek participants with noticeable PAF symptoms who have not succeeded with or cannot take certain heart rhythm drugs. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

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

The trial does not specify if you need to stop your current medications, but it mentions that participants should be refractory, intolerant, or contraindicated to certain heart rhythm drugs. It's best to discuss your specific medications with the trial team.

What prior data suggests that the VARIPULSE catheter system is safe for pulmonary vein isolation?

Research has shown that the VARIPULSE Catheter System is safe for treating atrial fibrillation (AF). Studies have found a very low rate of major complications during procedures, just 0.4%. This means that out of 1,000 people, only about 4 might experience serious issues. Importantly, no reports of strokes have occurred during treatment, a major concern for heart procedures.

The system is also highly effective, with 99.7% of treatments working well immediately. Most people who undergo the procedure see successful results right away. These findings suggest that the VARIPULSE Catheter System is well-tolerated and safe for those considering it for AF treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VARIPULSE Catheter System is unique because it uses pulsed field ablation (PFA) to treat atrial fibrillation, a method that stands out from the traditional thermal ablation techniques like radiofrequency and cryoablation. PFA targets heart tissue with precise electrical pulses, which can minimize damage to surrounding tissues and potentially reduce complications. Researchers are excited about this approach because it could offer a safer and more efficient treatment for patients with symptomatic paroxysmal atrial fibrillation, potentially improving outcomes and recovery times.

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

Research has shown that the VARIPULSE Catheter System could effectively treat paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. One study found that the system worked well for 74.6% of patients after 12 months. Another study showed a success rate of 75.6% for those who followed the treatment plan. Additionally, a smaller study reported a very high immediate success rate of 99.7%. These findings suggest that the VARIPULSE Catheter System, which participants in this trial will receive, has strong potential to help manage PAF. ^{1 3 5 6 7}

Who Is on the Research Team?

Biosense Webster, Inc. Clinical Trial

Principal Investigator

Biosense Webster, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with symptomatic paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. Participants should be experiencing symptoms and have not been successfully treated by other methods.

Inclusion Criteria

Able and willing to comply with all pre-, post-, and follow-up testing and requirements

I am willing and able to give my consent.

I have episodes of Atrial Fibrillation and am a candidate for a procedure to treat it.

Exclusion Criteria

Life expectancy less than 12 months

Current enrollment in an investigational study evaluating another device or drug

Any contraindications as defined in the Protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electrophysiology mapping and pulsed field ablation (PFA) for management of symptomatic paroxysmal atrial fibrillation using the VARIPULSE Catheter with a TRUPULSE Generator

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the index ablation procedure

7 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from documented atrial tachyarrhythmias episodes

Day 61-1095 post-index procedure

What Are the Treatments Tested in This Trial?

Interventions

• VARIPULSE Catheter System

Trial Overview The study tests the VARIPULSE catheter system, which uses pulsed field ablation to isolate pulmonary veins, aiming to manage atrial fibrillation. It focuses on long-term safety and effectiveness.

How Is the Trial Designed?

Group I: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator Experimental Treatment 1 Intervention

Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.

Who Is Running the Clinical Trial?

Biosense Webster, Inc.

Lead Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Citations

1. 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 ...

2. 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 ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12500624/

Pulsed field ablation for atrial fibrillation In the pivotal admIRE US IDE trial, the VARIPULSE™ system demonstrated a primary effectiveness of 74.6% at 12 months, with a major adverse event ...

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

Low acute complication rates with a variable loop pulsed ... Same-day discharge was achieved in 84.6% of patients. Among 174 patients with documented irrigation rate, 86.2% (n = 150) underwent ablation ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666501825004088

Real-world comparison of variable vs fixed-loop circular ... This is the first real-world comparison of two circular pulsed field ablation catheter systems: a variable loop circular catheter (VLCC; ...

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

Summary of Safety and Effectiveness Data (SSED) 5) Estimating the rate of major procedural complications in women undergoing paroxysmal AF ablation using the VARIPULSE Catheter System.

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

Low Acute Complication Rates with a Variable Loop ... This early real-world experience with the VLCC demonstrates a very low incidence of acute procedural complications (0.4%) across a ...