VARIPULSE + FARAWAVE Catheters for Atrial Fibrillation

(PERSIGMA RCT Trial)

Overseen By Jesal Parekh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Disqualifiers: Longstanding AF, Heart failure, Thromboembolic event, Severe pulmonary disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

466 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Who Is on the Research Team?

Biosense Webster, Inc. Clinical Trial

Principal Investigator

Biosense Webster, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able and willing to give my consent to join the study.

I have had symptomatic persistent atrial fibrillation for more than 7 days but less than a year.

Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria

I have had surgery or catheter ablation to treat atrial fibrillation.

I have had a blood clot in the past 6 months.

I have had a recent heart procedure or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation with either VARIPULSE or FARAWAVE PFA catheter

1 day

1 visit (in-person)

Early Follow-up

Participants are monitored for early onset primary adverse events

7 days

Long-term Follow-up

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

12 months

Regular visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• FARAWAVE PFA Catheter
• VARIPULSE PFA Catheter

How Is the Trial Designed?

Group I: VARIPULSE Pulsed Field Ablation (PFA) Catheter Experimental Treatment 1 Intervention

Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure.

Group II: FARAWAVE PFA Catheter Active Control 1 Intervention

Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure.

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