Pulse Field Ablation for Atrial Fibrillation

(AdmIRE Trial)

No longer recruiting at 35 trial locations

Overseen By Reecha Sharma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Must be taking: Antiarrhythmics

Disqualifiers: Persistent AF, Heart failure, Thromboembolic event, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with paroxysmal atrial fibrillation, a heart rhythm disorder causing occasional rapid and irregular heartbeats. The study aims to determine if a device called the VARIPULSE™ Catheter, used with the TRUPULSE™ Generator, is safe and effective over a year for isolating the pulmonary veins, which may help control symptoms. People who have experienced at least two symptomatic episodes of this condition in the last six months and have not found success with at least one type of medication might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to new treatment options.

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

The trial information does not specify if you need to stop taking your current medications. However, since participants must have failed at least one Class I or Class III antiarrhythmic drug, it might be necessary to discuss your current medications with the trial team.

What prior data suggests that this device is safe for pulmonary vein isolation?

Research has shown that the VARIPULSE™ Catheter, used with the TRUPULSE™ Generator for treating atrial fibrillation, is generally safe for patients. Previous studies have demonstrated strong safety results. For instance, one study found no cases of stroke and a high success rate of 99.7% in the initial treatment of nearly 800 patients.

The ADMIRE study also confirmed its safety and effectiveness, noting short procedure times and low X-ray exposure. These findings suggest that the treatment is well-tolerated, with very few serious side effects reported. This makes the VARIPULSE™ Catheter a promising option for those considering treatment for atrial fibrillation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pulse Field Ablation (PFA) for Atrial Fibrillation is unique because it uses a VARIPULSE™ Catheter to deliver pulsed electrical fields, which is a different approach compared to the standard treatments like radiofrequency or cryoablation. The key feature of this treatment is its precision; it targets heart tissue more selectively, potentially minimizing damage to surrounding areas. Researchers are excited about this technique because it promises to be quicker and safer, with less risk of complications such as damage to nearby structures or esophageal injury. This novel mechanism of action could lead to better outcomes and faster recovery times for patients with atrial fibrillation.

What evidence suggests that the VARIPULSE™ Catheter is effective for atrial fibrillation?

Research has shown that the VARIPULSE™ Catheter, when used with the TRUPULSE™ Generator, holds promise for treating paroxysmal atrial fibrillation, an irregular heartbeat. Studies found that about 75% of patients were free from this condition after 12 months. Another study reported that 87.7% of patients did not experience irregular heart rhythms at the 12-month mark. The treatment also demonstrated safety, with no major side effects reported. These findings suggest that the VARIPULSE™ system, which participants in this trial will receive, could be an effective option for people dealing with this heart issue. ^{2 3 4 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 who have symptomatic paroxysmal atrial fibrillation, have had at least one documented AF episode in the past year, and failed at least one antiarrhythmic drug. It's not for those with persistent AF, previous ablations for AF, severe heart conditions like unstable angina or severe mitral regurgitation, or women who are pregnant.

Inclusion Criteria

You have had at least one documented episode of atrial fibrillation within the past year.

You have tried at least one specific type of medication for heart rhythm problems and it didn't work.

You have experienced at least two episodes of symptomatic AF in the last six months before joining the study.

Exclusion Criteria

Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months

You have been diagnosed with atrial fibrillation that has lasted for more than 7 days.

You have atrial fibrillation caused by problems with your body's electrolytes, thyroid, or other non-heart-related issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

1 week

1 visit (in-person)

Initial Follow-up

Participants are monitored for primary adverse events post catheter insertion

1 week

1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from atrial tachyarrhythmia and quality of life improvements

12 months

Periodic visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• VARIPULSE™ Catheter

Trial Overview The trial tests the VARIPULSE™ Catheter with TRUPULSE™ Generator system's safety and effectiveness in isolating pulmonary veins to treat atrial fibrillation over a period of 12 months.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel 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

Published Research Related to This Trial

Ablation of paroxysmal atrial fibrillation (PAF) using a contact force (CF)-assisted catheter and a 3D mapping system without x-ray exposure was found to be safe and effective in a study involving 342 patients, with no significant differences in success rates compared to traditional x-ray methods.

The study demonstrated that while using the CF-assisted technique, the average fluoroscopy time during ablation was significantly lower (0 minutes) compared to the x-ray group (7.6 minutes), indicating a substantial reduction in radiation exposure without compromising the effectiveness of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconstruction left atrium and isolation pulmonary veins of paroxysmal atrial fibrillation using single contact force catheter with zero x-ray exposure: A CONSORT Study. Zhang, JQ., Yu, RH., Liang, JB., et al.[2022]

Pulsed field ablation achieved a 100% pulmonary vein isolation rate in 191 atrial fibrillation patients, demonstrating its efficacy as a safe and effective treatment option.

The procedure was streamlined to reduce average procedure times significantly, from 46 minutes to 38 minutes, while maintaining safety with no further strokes and a low incidence of silent cerebral injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation. Schmidt, B., Bordignon, S., Tohoku, S., et al.[2022]

In a study of 1,011 patients undergoing pulmonary vein radiofrequency catheter ablation for atrial fibrillation, the overall complication rate was 3.9%, indicating a relatively low incidence of early complications associated with this procedure.

No procedure-related deaths occurred, and while some complications like peripheral vascular issues and cardiac tamponade were noted, they were generally manageable, suggesting that the procedure is safe, especially compared to earlier years of AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Bertaglia, E., Zoppo, F., Tondo, C., et al.[2016]

Citations

1. 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 ...

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 800 ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.070333

Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation The 12-month primary effectiveness end point was 74.6%. The 1-year freedom from atrial fibrillation, atrial tachycardia, or atrial flutter ...

4. 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 ( ...

5. internationaljournalofcardiology.com internationaljournalofcardiology.com/article/S0167-5273(25)00178-0/fulltext

12-month outcomes of pulsed-field ablation with a variable- ... At 12 months, 87.7 % (95 % CI: 82.5 %–92.9 %) of patients remained free from atrial arrhythmia after the blanking period. No significant ...

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

Summary of Safety and Effectiveness Data (SSED) 2) Estimating the rate of serious device or serious procedure related adverse events for catheter ablation using the VARIPULSE Catheter System ...

7. 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.